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ACADEMIC REGULATIONS & SYLLABUS Faculty of Pharmacy Master of Pharmacy Programme [Pharmaceutics (Drug Regulatory Affairs)] www.Pharmainfo.Net www.Pharmainfo.Net
ACADEMIC
REGULATIONS
&
SYLLABUS
Faculty of Pharmacy
Master of Pharmacy Programme [Pharmaceutics (Drug Regulatory Affairs)]
www.Pharmainfo.Net
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Page 2 of 46
CHAROTAR UNIVERSITY OF
SCIENCE & TECHNOLOGY
Education Campus – Changa, (ECC), hitherto a conglomerate of institutes of professional education in Engineering,
Pharmacy, Computer Applications, Management, Applied Sciences, Physiotherapy and Nursing, is one of the
choicest destinations by students. It has been transformed into Charotar University of Science and Technology
(CHARUSAT) through an Act by Government of Gujarat. CHARUSAT is permitted to grant degrees under
Section-22 of UGC- Govt. of India.
The journey of CHARUSAT started in the year 2000, with only 240 Students, 4 Programmes, one Institute and an
investment of about Rs. 3 Crores (INR 30 million). At present there are seven different institutes falling under ambit
of six different faculties. The programmes offered by these faculties range from undergraduate (UG) to Ph.D degrees
including M.Phil. These faculties, in all offer 23 different programmes. A quick glimpse in as under:
Faculty Institute Programmes
Offered
Faculty of Technology & Engineering Charotar Institute of Technology B.Tech
M.Tech
Ph.D
Faculty of Pharmacy Ramanbhai Patel College of Pharmacy B.Pharm
M.Pharm
Ph.D
Faculty of Management Studies Indukaka Ipcowala Institute of Management M.B.A
PGDBM *
Ph.D
Faculty of Computer Applications Charotar Institute of Computer Applications M.C.A
Ph.D
Faculty of Applied Sciences P.D.Patel Institute of Applied Sciences M.Sc
M.Phil
Ph.D
Faculty of Medical Sciences Charotar Institute of Physiotherapy
Charotar Institute of Nursing
B.PT
B.Sc (Nursing)
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The development and growth of the institutes have already led to an investment of over Rs.63 crores (INR 630
Million). The future outlay is planned with an estimate of Rs. 250 Crores (INR 2500 Million).
The University is characterized by state-of-the-art infrastructural facilities, innovative teaching methods and highly
learned faculty members. The University Campus sprawls over 100 acres of land and is Wi-Fi enabled. It is also
recognized as the Greenest Campus of Gujarat.
CHARUSAT is privileged to have 300 core faculty members, educated and trained in Stanford, IITs, IIMs and
leading Indian Universities, and with long exposure to industry. It is also proud of its past students who are
employed in prestigious national and multinational corporations.
From one college to the level of a forward-looking University, CHARUSAT has the vision of entering the club of
premier Universities initially in the country and then globally. High Moral Values like Honesty, Integrity and
Transparency which have been the foundation of ECC continue to anchor the functioning of CHARUSAT. Banking
on the world class infrastructure and highly qualified and competent faculty, the University is expected to be
catapulted into top 20 Universities in the coming five years. In order to align with the global requirements, the
University has collaborated with internationally reputed organizations like Pennsylvania State University – USA,
University at Alabama at Birmingham – USA, Northwick Park Institute –UK, ISRO, BARC, etc.
CHARUSAT has designed curricula for all its programmes in line with the current international practices and
emerging requirements. Industrial Visits, Study Tours, Expert Lectures and Interactive IT enabled Teaching Practice
form an integral part of the unique CHARUSAT pedagogy.
The programmes are credit-based and have continuous evaluation as an important feature. The pedagogy is student-
centred, augurs well for self-learning and motivation for enquiry and research, and contains innumerable unique
features like:
• Participatory and interactive discussion-based classes.
• Sessions by visiting faculty members drawn from leading academic institutions and industry.
• Regular weekly seminars.
• Distinguished lecture series.
• Practical, field-based projects and assignments.
• Summer training in leading organizations under faculty supervision in relevant programmes.
• Industrial tours and visits.
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• Extensive use of technology for learning.
• Final Placement through campus interviews.
Exploration in the field of knowledge through research and development and comprehensive industrial linkages will
be a hallmark of the University, which will mould the students for global assignments through technology-based
knowledge and critical skills.
The evaluation of the student is based on grading system. A student has to pursue his/her programme with diligence
for scoring a good Cumulative Grade Point Average (CGPA) and for succeeding in the chosen profession and life.
CHARUSAT welcomes you for a Bright Future
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CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY
Faculty of Pharmacy
ACADEMIC REGULATIONS
M. Pharm. [Pharmaceutics (Drug Regulatory Affairs)] Programme
Charotar University of Science and Technology (CHARUSAT)
CHARUSAT Campus, At Post: Changa – 388421, Taluka: Petlad, District: Anand
Phone: 02697-247500, Fax: 02697-247100, Email: [email protected]
www.charusat.ac.in
Year – 2012
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CHARUSAT
FACULTY OF PHARMACY
ACADEMIC REGULATIONS
M. Pharm. [Pharmaceutics (Drug Regulatory Affairs)] Programme
To ensure uniform system of education, duration of post graduate programmes, eligibility criteria for and mode
of admission, credit load requirement and its distribution between courses and system of examination and other
related aspects, following academic rules and regulations are recommended.
1. System of Education
The Semester system of education should be followed across The Charotar University of Science and Technology
(CHARUSAT) at Master’s levels. Each semester will be at least of 90 working days duration. Every enrolled
student will be required to take a specified load of course work in the chosen subject of specialization and also
complete a project/dissertation if any.
2. Duration of Programme
Postgraduate programme (M.Pharm)
Minimum 4 semesters (2 academic years)
Maximum 6 semesters (3 academic years)
Maximum limit can be extended by one or two semesters subject to approval of University on case to case basis.
3. Eligibility for admissions
As decided from time to time by the Government of Gujarat and CHARUSAT
4. Mode of admissions
As decided from time to time by the Government of Gujarat and CHARUSAT
5. Programme structure and Credits
A student admitted to a program should study the courses and earn credits specified in the course
structure. Please refer detailed syllabus.
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6. Attendance
All activities prescribed under these regulations and listed by the course faculty members in their respective
course outlines are compulsory for all students pursuing the M. Pharm. programme. No exemption will be
given to any student from attendance except on account of serious personal illness or accident or family
calamity that may genuinely prevent a student from attending a particular session or a few sessions.
However, such unexpected absence from classes and other activities will be required to be condoned by the
Principal.
Student attendance in a course should be 80%.
7. Course Evaluation
7.1 The performance of every student in each course will be evaluated as follows:
7.1.1. Internal evaluation by the course faculty member (s) based on continuous assessment, for 30% of the
marks for the course; and
7.1.2 Final examination by the University through written paper or practical test or oral test or presentation
by the student or a combination of any two or more of these, for 70% of the marks for the course.
7.1.3 Theory and Practical component of the same course shall be considered as separate courses.
7.2 Internal Evaluation (Theory)
The distribution of marks for calculating the internal marks in every course of theory shall be:
Test * 20 Marks
Seminar/quiz/viva 10 Marks
___________________________________________________________________________
Total 30 Marks
* One test (60 marks, 2.5 hours duration) shall be conducted as per the schedule to be notified by the
institute for every course in a semester.
7.3. Internal evaluation (Practicals)
The distribution of marks for calculating the internal marks in every course of practical shall be:
Performance of the exercises * 15 Marks
Viva 10 Marks
Quiz 05 Marks
Total 30 Marks
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*One test (60 marks, 6 hours duration) shall be conducted as per the schedule to be notified by the Institute
for every course of practical in a semester.
7.4 University Examination
7.4.1 The final examination by the University for 70% of the evaluation for the course will be through
written paper or practical test or oral test or presentation by the student or a combination of any
two or more of these.
In order to earn the credit in a course a student has to obtain grade other than FF.
7.5 Performance at University Examination
7.5.1 Minimum performance with respect to university examination as well as overall (university + internal)
will be an important consideration for passing a course.
Details of minimum percentage of marks to be obtained in the examinations are as follows:
Minimum marks in University
Examination for every course
Minimum marks Overall (internal +
university examination) for every course
40% 50%
7.5.2 If a candidate obtains minimum required marks per course in university examination but fails to obtain
minimum required overall marks, he/she has to repeat the university examination till the minimum
required overall marks are obtained.(As per the clause 7.5.1)
8. Grading
8.1 The total of the internal evaluation marks and final University examination marks in each course will be
converted to a letter grade as well as to a ten-point scale as per the following scheme:
Grading Scheme:
Range of Marks (%) ≥80 <80
≥75
<75
≥70
<70
≥65
<65
≥60
<60
≥55
<55
≥50
<50
Letter Grade AA AB BB BC CC CD DD FF
Grade Point 10 9 8 7 6 5 4 0
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8.2 The student’s performance in any semester will be assessed by the Semester Grade Point Average (SGPA).
Similarly, his/her performance at the end of two or more consecutive semesters will be denoted by the
Cumulative Grade Point Average (CGPA). The SGPA and CGPA are defined as follows:
(i) SGPA = ∑ Ci Gi / ∑ Ci where Ci is the number of credits of course i
Gi is the Grade Point for the course i
and i = 1 to n, n = number of courses in the semester
(ii) CGPA = ∑ Ci Gi / ∑ Ci where Ci is the number of credits of course i
Gi is the Grade Point for the course i
and i = 1 to n, n = number of courses of all semesters up to which
CGPA is computed.
No student will be allowed to move further if CGPA is less than 3 at the end of every academic year.
9. Award of Degree
9.1 Every student of the programme who fulfils the following criteria will be eligible for the award of the
degree:
9.1.1 He/She should have earned at least minimum required credits as prescribed in course structure; and
9.1.2 He/She should have cleared all external and overall evaluation components in every course; and
He/She should have secured a minimum CGPA of 5.0 at the end of the programme;
In addition to above, the student has to complete the required formalities as per the regulatory bodies,
if any.
9.2 The student who fails to satisfy minimum requirement of CGPA will be allowed to improve the grades so as
to secure a minimum CGPA for award of degree. Only latest grade will be considered.
10. Award of Class
The class awarded to a student in the programme is decided by the final CGPA as per the following scheme:
Distinction: CGPA ≥ 7.5
First class: CGPA≥ 6.0 & <7.5
Second Class: CGPA≥ 5.0 & <6.0
11. Transcript
The transcript issued to the student at the time of leaving the University will contain a consolidated record
of all the courses taken, credits earned, grades obtained, SGPA,CGPA, class obtained, etc.
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CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY M. PHARM [Pharmaceutics (Drug Regulatory Affairs)]
1st Semester
Scheme of Teaching
Course Contact Hours/Week Credits
Code
Name
Theory
Seminar
Practical
Total Theory+ Seminar
Practical
Total
PH821 Analytical Techniques 3 -- 6 9 3 3 6
PH883 Pharmacokinetics 3 -- -- 3 3 -- 3
PH881.01 Drug Regulatory
Affairs–I
3
2
4
9 5
2
7
PH881.02 Fundamentals of
Pharmaceutical Product Development
3 --
6
9
3
3
6
PH881.03 GMP, Quality Assurance &
Process Validation
4
2
--
6
6
--
6 Total 16 4 16 36 20 8 28
Total Credits of 1st semester: 28
Scheme of Evaluation Course Theory Practical
Code
Name
University
Institute
Total
University
Institute
Total Test Seminar
PH821 Analytical Techniques 70 30 -- 100 70 30 100
PH883 Pharmacokinetics
70
30
--
100 -- -- --
PH881.01 Drug Regulatory
Affairs–I
70
20
10
100
70
30
100
PH881.02 Fundamentals of
Pharmaceutical Product Development
70
30
--
100
70
30
100
PH881.03
GMP, Quality Assurance & Process
Validation
70
20
10
100
--
--
--
Total 350 130 20 500 210 90 300
Total marks of 1st semester: 800
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CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY M. PHARM [Pharmaceutics (Drug Regulatory Affairs)]
2nd Semester
Scheme of Teaching
Course Contact Hours/Week Credits
Code
Name
Theory
Seminar
Practical
Project
Total Theory+ Seminar
Practical
Project
Total
PH823 Biostatistics 2 -- 4 -- 6 2 2 -- 4
PH824 Research Methodology 4 -- - -- 4 4 -- -- 4
PH881.04 Drug Regulatory Affairs–II 3 2 2 -- 7 5 1 -- 6
PH881.05 Drug Regulatory Affairs–III 3 --
3 -- 6 3 1.5 -- 4.5
PH881.06 Pharmaceutical Formulations
& Advanced Technology
3 2
3
-- 8 5
1.5
--
6.5
PH881.07 Dissertation part-I -- -- -- 5 5 -- -- 2 2
Total 15 4 12 5 36 19 6 2 27
Total Credits of 2nd semester: 27
Scheme of Evaluation
Course
Theory Practical Project
University Institute
Total
University
Institute
Total
University
Institute
Total Code Name Theory seminar
PH823 Biostatistics 35 15 -- 50 70 30 100 -- -- --
PH824 Research
Methodology
70
30
--
100
--
--
--
--
--
--
PH881.04 Drug Regulatory
Affairs–II
70
20
10
100
70
30
100
--
--
--
PH881.05 Drug Regulatory
Affairs–III
70
30
--
100
70 30 100 --
--
--
PH881.06
Pharmaceutical Formulation &
Advanced Technology
70
20
10
100
70
30
100
--
--
--
PH881.07 Dissertation part-I
--
--
--
--
--
--
--
--
50
50
Total 315 115 20 450 280 1200
400 -- 50 50
Total marks of 2nd semester: 900
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CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY M. PHARM [Pharmaceutics (Drug Regulatory Affairs)]
3rd SEMESTER Scheme of teaching
Course Contact Hours/Week Credits
Code
Name Theory
Practical
Project
Total
Theory
Practical
Project
Total
PH922
Intellectual Property
Rights
4
--
--
4
4
--
--
4
PH981.01 Dissertation
Part-II
--
--
32
32
--
--
22
22
Total 4 -- 32 36 4 -- 22 26 Total credits of 3rd semester: 26
Scheme of Evaluation
Course Theory Practical Project
University
Institute
Total
University
Institute
Total
University
Institute
Total Code Name
PH922
Intellectual Property Rights
70
30
100
---
--
--
--
--
--
PH981.01Dissertation
Part-II
--
--
--
--
--
--
400
150
550
Total 70 30 100 -- -- -- 400 150 550
Total marks of 3rd semester : 650
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CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY M. PHARM [Pharmaceutics (Drug Regulatory Affairs)]
4th SEMESTER Scheme of teaching
Part I: 10 weeks
Course Contact Hours/Week Credits Code Name Theory Practical Project Total Theory Practical Project Total
PH981.02
Dissertation Part-III
--
--
36
36
--
--
26
26
Part II: 5 Weeks
PH981.03
Industrial Training
--
--
--
--
--
--
2
2
Total -- -- -- -- -- -- 28 28
Total Credits of 4th semester :28
Scheme of Evaluation
Course
Theory Practical Project
University
Institute
Total
University
Institute
Total
University
Institute
Total Code Name
PH981.02 Dissertation
Part-III
--
--
--
--
--
--
500 150
650
PH981.03
Industrial Training
--
--
--
--
--
--
--
50
50
Total -- -- -- -- -- -- 500 200 700
Total Marks of 4th Semester : 700
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M. Pharm. [Pharmaceutics (Drug Regulatory Affairs)] Programme
SYLLABI
(Semester – 1)
CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY
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ANALYTICAL TECHNIQUES (PH821)
(Theory & Practical)
Credits: 3: Theory Contact hrs per week: 3: Theory
3: Practical 6: Practical
Objective of the Course:
To make students familiar with the principles of modern analytical techniques and it’s application in
pharmacy.
Student Learning Outcomes/Objectives:
At the end of the course, the student will be able to understand the fundamental concept of modern
analytical techniques, which is important for qualitative as well as quantitative analysis of drug substances
and drug product.
Instructional Methods and Pedagogy:
Faculty member/s shall explain in a class room using black board and multimedia projector.
Outline of the Course:
No. Unit Minimum No.
of Contact Hours Approx.
Weightage % 1 UV – Visible spectroscopy 6 14 2 Infrared spectroscopy 4 8
3 Nuclear Magnetic Resonance Spectroscopy
8 20
4 Mass Spectroscopy 6 14 5 Thermal Methods of Analysis 3 6 6 X-Ray Diffraction Methods 3 6 7 Chromatographic techniques 8 20 8 Analytical Method Validation 2 3 9 Electrophoresis 3 6
10
Application of Transmittance Electron Microscopy (TEM) and Scanning Electron Microscopy (SEM).
2 3
Total 45 100 %
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Detailed Syllabus (Theory):
No. Unit Details Hrs.
1. UV – Visible spectroscopy: Theory, chromophores and their interaction with EMR, solvent effects,
instrumentation (components and their function) & applications including multi-component assay
and derivative spectra. Woodward-Fischer rules for calculating absorbance maximum and
interpretation of spectra.
6
2. Infrared spectroscopy: Introduction, basic principles, instrumentation (components and their
function), sampling techniques, interpretation of spectra and applications. Theory and applications
of FTIR, ATR and NIR.
4
3. Nuclear Magnetic Resonance Spectroscopy: Fundamental principle and theory of proton NMR,
instrumentation, solvents, chemical shift, spin-spin coupling, coupling constant, spin-spin
decoupling, proton exchange reactions, simplification of complex spectra, FT-NMR, 2D-NMR,
applications in pharmacy and interpretation of spectra. 13 C-NMR introduction, natural abundance,
13 C-NMR spectra and its structural applications.
8
4. Mass Spectroscopy: Basic principle and instrumentation, ion formation and type, fragmentation
process and fragmentation pattern, chemical ionization mass spectroscopy (CIMS), field ionization
MS (FIMS), Fast atom bombardment MS (FAB-MS), matrix assisted laser desorption/ ionization
MS (MALDI-MS), Interpretation of spectra and application in pharmacy, Surface Ionization MS(SI-
MS).
6
5. Thermal Methods of Analysis: Theory, instrumentation and application of thermogravimetric
analysis (TGA), Differential Thermal Analysis (DTA), Differential Scanning Calorimetry (DSC) and
Thermo Mechanical Analysis (TMA).
3
6. X-Ray Diffraction Methods: Introduction, generation of X-rays, X-ray diffraction, Bragg’s Law, X-ray
powder diffraction, interpretation of diffraction pattern and applications. 3
7. Chromatographic techniques: Classification of chromatographic methods based on mechanism of
separation. Theories of chromatographic separation. Principles, elution techniques, instrumentation,
derivatization and application of GC, HPLC, HPTLC. Principles, elution techniques, applications of
ion exchange and ion pair chromatography, affinity chromatography, Size exclusion
chromatography, chiral chromatography, super fluid chromatography (SFC), GC-MS, short column
chromatography, flash chromatography, medium pressure LC and LC-MS.
8
8. Analytical Method Validation: Basis concepts for development and validation of analytical and bio
analytical method as per ICH guidelines. 2
9. Electrophoresis: Theory and principles, classifications, instrumentation, moving boundary
electrophoresis, Zone Electrophoresis (ZE), Isoelectric focusing (IEF) and applications. 3
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10. Application of Transmittance Electron Microscopy (TEM) and Scanning Electron Microscopy
(SEM). 2
Detailed syllabus (Practicals): To illustrate the topics included under theory.
Recommended study materials:
1. Principles of Instrumental Analysis, Skoog, Hollar and Nieman, Saunders College Publishers,
Philadelphia.
2. Instrumental Methods of Analysis, Willard, Merritt, Dean and Settle, CBS publishers and
Distributers, Delhi.
3. Instrumental Methods of Chemical Analysis, G. W. Ewing, McGraw Hill Book Co, NY.
4. Instrumental Methods of Chemical Analysis, B.K. Sharma, Goel Publication House, Meerut, India.
5. United States Pharmacopoeia-27(NF-22), 2004, United State of Pharmacoppeal convention, INC,
12601 Twinbrook Parkway, Rockville, MD 20852.
6. British Pharmacopoeia, 2004, The British Pharmacopoeia commission office, Market Tower, Nine
Elms Lane, London.
7. Indian Pharmacopoeia-2007, Indian pharmacopoeia commission, Sector-23, Raj Nagar, Ghaziabad.
8. Remington’s Pharmaceutical Sciences, J. P. Remington, Mack Pub. Co., Pennsylvania.
9. Statistics for Analytical Chemists, T Caulcutt and R. Boddy, Chapman & Hall, London.
10. Modern Methods of Pharmaceutical Analysis, Vol 1, 2, RE Schirmer, Franklin Book Co, PA.
11. Spectroscopic identification of organic compounds. R.M. Silverstein, G.C. Bassler, T.C. Morrill, Pub:
John Wiley and Sons, NY.
12. Spectroscopic identification of organic compounds. John Dyer, Willy, NY.
13. Organic Spectroscopy W. Kemp, NY.
14. NMR spectroscopy (Basic Principles, concepts and application in Chemistry) Herald Gunther, (John
Wiley and Sons), NY.
15. Fundamentals of Mathematical Statistics, S.C. Gupta and V.K. Kapoor (Sulthyan Chand and Sons),
New Delhi.
16. Pharmaceutical Analysis – Modern Methods – Part A, Part B, J. W. Munson, Marcel Dekker, NY.
17. Practical Pharmaceutical Chemistry, Part two, edited by A. H. Beckett & J. B. Stenlake
18. Identification of Drugs and Pharmaceutical Formulations by Thin Layer Chromatography, 2nd Edition,
P. D. Sethi, CBS Publishers and Distributers, New Delhi.
19. HPTLC – Quantitative Analysis of Pharmaceutical Formulations – P. D. Sethi, CBS Publishers and
Distributers, New Delhi.
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20. Stereo Chemistry – Conformation and Mechanism by P. S. Kalsi, New Age International Publishers.
21. Chromatographic Analysis of Pharmaceuticals, A. John, Adamovics, Cytogan Corporation, Princeton,
NJ.
22. Clerk’s analysis of Drugs and Poisons, A.C. Moffet, M. D. Osselton, B. Widdop L. Y. Galichet,
Pharmaceutical Press.
23. Relevant articles from journals.
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PHARMACOKINETICS (PH883) Credits: 3: Theory Contact hrs per week: 3: Theory Objectives of the course: To Study the absorption, metabolism, distribution and excretion of drugs. The primary goal of the course related to pharmacokinetics is to provide a conceptual and quantitative background in pharmacokinetic theory and applications. This will be needed to pursue studies in clinical pharmacokinetics. The overall study of biopharmaceutics and pharmacokinetics will help in drug delivery system design and development of pharmaceutical formulations. Students learning outcomes/objectives:
• Students will be able to estimate pharmacokinetic parameters using plasma and urine drug level data.
• Students will be able to predict the effects of various physicochemical, biochemical, physiological and pathological processes on the kinetics and extent of drug absorption, distribution, and elimination.
Instructional Methods and Pedagogy: Through discussion in a class-room, and performing experiments related to Biopharmaceutics & Pharmacokinetics studies. Outline of the Course:
No Unit Minimum No. Of
Contact Hours Approx.
Weightage %
1 ADME Characteristics of drug 18 40 2 Pharmacokinetics 14 31 3 Pharmacokinetics of Multiple Dosing 3 7 4 Non-linear Pharmacokinetics 2 4 5 Bioavailability & Bioequivalence 5 11
6 In-vitro In-vivo Correlation (IVIVC) 3 7
Total 45 100%
Details of Syllabus: 1 ADME Characteristics of drug:-
Drug Absorption: General consideration, absorption / drug transport mechanisms, role of sorption promoters, factors affecting absorption, absorption of drug of through routes other then oral,in-vitro, in-situ, in-vivo and cell line (Caco – 2) study methods of determining absorption. Drug Distribution: Factors affecting drug distribution, protein & tissue binding, Apparent volume of drug distribution Drug Metabolism (Biotransformation): Biotransformation, factors affecting biotransformation, Phase I & Phase-II reactions Drug Excretion: Glomerular filtration, tubular secretion, tubular reabsorption, Factors affecting drug excretion.
2 Pharmacokinetics:-
• One compartment and two compartments open model: i.v. bolus administration, i.v. infusion, extra vascular administration
• Multicompartment model
• Application of Pharmacokinetics: new drug development, Design of dosage forms and novel drug delivery systems, Case studies based on pharmacokinetic principles
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• Determination of various pharmacokinetic parameters
• Absorption rate constant, elimination rate constant, biological half life, % drug metabolized, apparent volume of distribution, excretion rate constant, Clearance ( including the concept of renal & non-renal clearance), Kinetics of protein binding and other Pharmacokinetic parameters
• Softwares used for determination of pharmacokinetic parameters
3 Pharmacokinetics of Multiple Dosing:
Adjustment of dosage in renal & hepatic impairment, individualization of therapy, therapeutic drug monitoring, Kinetics of sustained release
4 Non-linear Pharmacokinetics: Causes of non-linearity, estimation of various parameters and
bioavailability of drugs that follow non-linear kinetics 5 Bioavailability & Bioequivalence: Objectives of bio-availability & bioequivalence studies,
Measurements of bio-availability, Concept of Bioequivalence, Experimental Designs in Bioequivalence study (Cross over, Latin Square, Balance incomplete block design etc), Regulatory aspects of bio-availability and bioequivalence studies for conventional dosage forms and controlled drug delivery systems
6 In-vitro In-vivo Correlation (IVIVC):- Concept, Methods of establishing IVIVC, Factors effecting
IVIVC. Application of IVIVC for biowaivers of immediate release dosage forms. IVIVC for Sustain Release and controlled release dosage forms
Practicals: To illustrate the topics included under theory Recommended books: (Latest edition of the books should be referred)
1. Pharmacokinetics, M Gibaldi, Marcel Dekker, Inc., New York. 2. Remington’s Pharmaceutical Sciences, Mack publishing company, Pennsylvania. 3. Biopharmaceutics and Pharmacokinetics- A Treatise, D.M. Brahmankar and Sunil B. Jaiswal,
Vallabh Prakashan Pitampura, Delhi. 4. Clinical Pharmacokinetics, Concepts and Applications, M. Rowland and T. N. Tozer, Lippincott
Williams & Wilkins, Philadelphia 5. Biopharmaceutics and Clinical Pharmacokinetics- An introduction; Robert. E. Notari, Marcel
Dekker Inc, New York 6. Encyclopedia of Pharmaceutical Technology, James Swarbrick and C.Boylan, Marcel Dekker Inc,
New York, 7. Pharmaceutical dissolution testing, U.V. Banaker, Marcel Dekker, Inc., New York. 8. The United States Pharmacopoeia-27 (NF-22),2004, United State of Pharmacoppeal convention,
INC, 12601 Twinbrook Parkway, Rockville, MD 20852. 9. Applied Biopharmaceutics and pharmacokinetics, Leon Shargel, Mc Graw Hill, 10. Pharmacokinetics, Welling and Tse, Marcel Dekker, Inc., New York. 11. Biopharmaceutics and Clinical Pharmacokinetics, Niazi, Prentice Hall, London 12. Dose finding in Drug Development, N. Ting, Springer, U.K. 13. Drug disposition & Pharmacokinetics, S.H. Curry, Pharma Med Press , Hyderabad 14. Introduction of Biopharmaceutics & Pharmacokinetics, H. P. Tipnis and M. S. Nagarsenkar, Nirali
Prakashan, Pune. 15. Textbook of Biopharmaceutics & Pharmacokinetics, Javed Ali, R. K. Khar and Alka Ahuja, Birla
Publication, Delhi. 16. Biopharmaceutics & Pharmacokinetics, Venkateshwarlu, India
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DRUG REGULATORY AFFAIRS-I (PH881.01) (Theory & Practical)
Credits: 3: Theory Contact hrs per week: 3: Theory 2: Practical 4: Practical 2: Seminar 2: Seminar
Objectives of the ourse:
To Study the basics of the drug regulatory affairs as per the Indian legislation. The primary goal of the course related to introduce the basic concepts of drug regulatory affairs with special emphasis on the Indian pharmaceutical legislations.
Students learning outcomes/objectives:
• Students will be aware of the drug regulatory affairs. • Students will be able to understand the pharmaceutical legislations of India.
Instructional Methods and Pedagogy: Through discussion in a class room, performing practicals, preparing assignments and
case studies.
Outline of the Course:
No
Unit
Minimum No.of
Contact Hours
Approx.
Weightage %
1 Pharmaceutical legislations in India 25 53 2 Globalization of drug industries 5 12 3 Schedule M & U requirements 5 12 4 Legal Environment of Business 6 13 5 Pharmaceutical Regulatory Process in India 4 10
Total 45 100% Details of Syllabus:
1. Pharmaceutical legislations in India: I. Origin, development, scope, objectives and nature of Pharmaceutical legislation in
India. History and ethics of profession of Pharmacy. II. A study of regulatory aspects that affect drug product design, manufacture and
distribution in India with special emphasis on the detailed study of the following Acts / Laws (with latest amendments)
• The Drugs and Cosmetics Act, 1940 and Rules there under.
• The Narcotics Drugs and Psychotropic Substances Act.
• Medicinal and Toilet Preparations (Excise Duties) Act, 1955.
• Drugs (Price Control) Order in force.
• Copy Right Act, Trade Mark Act, and Biodiversity Act,
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• The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1955.
• Prevention of Cruelty to Animals Act.
• Factory’s Act.
• The Environmental Protection Act
• Consumer Protection Act
• Law of Torts
• Law of Contracts
• Monopolistic & Restrictive Trade Practices Act 2. Globalization of drug industries: Export Import Policy of drugs, WHO –certification,
Trademarks and copyrights.
3. Schedule M & U requirements- Product development stage documentation,
factory procedures – Standard operating procedures (SOPs) and standard test Procedures (STPs).
4. Legal Environment of Business- Need for government regulations; financial
regulations, SEBI, BIFR, FEMA and others, Contract Act and Sale of Goods Act, Company Act, Corporate tax laws – Direct and Indirect.
5. Pharmaceutical Regulatory Process in India: Hierarchy and working flow of FDA in
India, Roles of DCGA and CDSCO in drug control, Drug Control Authority and its documentation in the state.
Practicals / Assignments / Case Studies: To illustrate the topics included under theory Recommended books: (Latest edition of the books should be referred)
1. Drugs and Cosmetics Act, 1940 and its rules, published by Ministry of health and family welfare, Government of India.
2. Pharmaceutical Jurisprudence, G.K. Jani. 3. The Pharmaceutical Regulatory Process, 2nd ed. – Ira R. Berry, Robert P. Martin 4. Medical Product Regulatory Affairs: Pharmaceutical , Diagnostics, Medical
Devices – John J. Tobin and Gary Walsh. 5. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices and
Biologics, 2nd ed. – Douglas J. Pisano and David S. Mantus 6. Good Drug Regulatory Practices: a Regulatory Affairs Quality Manual (Good
Drug Development Series) – Helene I. Dumitriu. 7. Pharmaceutical Patent Law – John R. Thomas. 8. http://cdsco.nic.in 9. Original laws published by Govt. of India. 10. Text Book of Forensic Pharmacy by Mithal B. M.; Vallabh Prakashan, New Delhi. 11. Laws of Drugs in India by Hussain. 12. Text Book of Forensic Pharmacy by Jain N. K.; Vallabh Prakashan, New Delhi.
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FUNDAMENTALS OF PHARMACEUTICAL PRODUCT DEVELOPMENT (PH881.02)
(Theory & Practical) Credits: 3: Theory Contact hrs per week: 3: Theory
3: Practical 6: Practical
Objectives of the course:
To integrate aspects of physical pharmacy, stability requirements and drug delivery for the development of Pharmaceutical Dosage Forms.
Students learning outcomes/objectives:
To develop the ability to effectively apply knowledge of excipients, preformulation studies, s t a b i l i t y , evaluation in the formulation of pharmaceutical products and drug delivery systems.
Instructional Methods and Pedagogy:
Through discussion in a class-room, and performing experiments related to Product development studies.
Outline of the course:
No. Unit Minimum no. of Contact Hours.
Aprrox. Weightage %
1 Preformulation 6 15
2 Solid state Pharmaceutics and Characterization 8 18
3 Excipients for pharmaceutical formulations. 6 13
4 Stability of drug and dosage forms. 7 16
5 Drug diffusion & dissolution 8 18
6 Drug Carrier Delivery Systems 10 20
Total 45 100% Detailed Syllabus:
1. Preformulation: Detailed study of physical, chemical and pharmaceutical parameters influencing formulation of drugs.
2. Solid state Pharmaceutics and Characterization: Application of phase rule to the
characterization of polymorphic systems, structural aspect of polymorphism, hydrates and solvents, generation of polymorphs, hydrates, solvates and amorphous solids, methods for the characterization of polymorphs and solvates, effect of polymorphism on solubility and dissolution rate, effect of pharmaceutical processing on drug polymorphs and solvates, impact of polymorphism on quality of lyophilized products.
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3. Excipients for Pharmaceutical formulations:
• Factors affecting the selection(including safety considerations), drug-excipient and excipient- package interactions, Study of newer excipients like cyclodextrin, ion exchange resins, film coating materials, superdisintegrants, directly compressible vehicles, surfactants, thickeners. Co-processed excipients.
• Guidelines for excipients: IIG, GRAS, NICNAS.
4. Stability of drug & dosage forms: Degradation of drug in solid state & solid dosage
forms, stabilization methods, importance of stability indicating assay in stability evaluation, stability evaluation of disperse systems.
5. Drug Diffusion & Dissolution:
• Drug diffusion: steady state diffusion, diffusion principles in biological systems, thermodynamics of diffusion, Fick’s Law of diffusion.
• Theory of dissolution, factors influencing dissolution, interpretation of dissolution rate data, Comparison of dissolution profile by model independent (similarity and dissimilarity factor) and dependent methods.
• Biopharmaceutical classification system (BCS), its significance in context of dissolution study and dosage form development.
• Selection of dissolution media. • Pharmacopoeial & Non-Pharmacopoeial dissolution testing devises, Automation in
dissolution testing,
• Dissolution of immediate release and modified release dosage forms
6. Drug Carrier Delivery Systems: Structure, stability, composition, methods of preparation, applications in drug delivery, drug targeting and commercial aspects of following: Particulate Carriers, Vesicular carriers, Cellular carriers, Monoclonal antibodies and other Carriers
Practicals: To illustrate the topics included under theory Recommended books: (Latest edition of the books should be referred)
1. Drug Stability, J. T. Carstensen, Marcel Dekker, New York. 2. Theory & Practice of Industrial Pharmacy, L. Lachman, Varghese Publication,
Bombay. 3. Modern Pharmaceutics, G.S. Banker and C.T. Rhodes, Marcel Dekker, NY. 4. Physical Characterization of Pharmaceutical Solids, H. G. Brittain, Marcel Dekker,
NY. 5. Physical Pharmacy, A. Martin, Lea and Febiger, Philadelphia. 6. Pharmaceutical dissolution testing, U.V. Banaker, Marcel Dekker, Inc., New York. 7. Pharmaceutical Dosage Forms : Parenteral Medications, Avis K. E., Leon Lachman
and H. Lieberman, Marcel Dekker, New York 8. Pharmaceutical Dosage Forms : tablets, Lierberman H. A. and Leon Lachman, ,
Marcel Dekker, New York 9. Oral lipid based formulations; D.J. Hauss, Informa Healthcare, New York 10. Polymorphism in Pharmacetucial solids: H.G. Brittain, Marcel Dekker, New York 11. Biodegradable polymers as drug delivery systems, edited by M.Chasin, R.langer,
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Marcel Dekker, New York. 12. Handbook of Preformulations, S. K. Niazi, Informa Healthcare, New York. 13. Pharmaceutical Preformulations & Formulation, edited by Marks Gibson,
Interpharm/CRC, Boca Raton, Florida, USA. 14. Novel Drug Delivery Systems, Y.W. Chien, Marcel Dekker, Inc., New York. 15. Progress in Controlled and Novel Delivery Systems, edited by N.K. Jain, CBS Publishers
& Distributors, New Delhi. 16. Targeted & Controlled Drug Delivery, S. P. Vyas and R. K. Khar, CBS Publishers &
Distributors, New Delhi. 17. Advances in Controlled and Novel Drug Delivery, Edited by N.K. Jain, CBS
Publishers & Distributors, New Del
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GMP, Quality Assurance & Process Validation (PH 881.03) (Theory)
Credits 4: Theory Contact hrs per week 4: Theory 2: Seminar 2: Seminar
Objectives of the course:
• To provide the student with understanding of various facets of Quality Assurance System, Good Manufacturing Practices and Process Validation.
Students learning outcomes/objectives
• The basic understanding acquired by the student at the end of the course shall help him/her to appreciate the Quality Assurance System of a Pharmaceutical Industry during his/her training.
Instructional Methods and Pedagogy:
• The course employs lectures and class discussions. It also includes presentation by a students on a specific topic assigned to them by the faculty
• Presentation on a case related to the course
• Visit to Pharmaceutical Industry
Outline of the course:
No. Unit Minimum no. Of Contact Hours.
Aprrox. Weightage %
1 Quality Assurance 25 45
2 Good Manufacturing Practices (GMP) 18 28
3 Process Validation 17 27
Total 60 100%
Detailed Syllabus: 1. Quality Assurance:
• Role of raw material testing, finished product testing, in process quality control in assuring quality of drug products to consumers
• Role of quality audit & quality circle in quality assurance
• Application of Process Analytical Technology (PAT) in quality assurance
• Quality by Design (QbD)
• GLP
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2. Good Manufacturing Practices (GMP) :
• Role of GMP in quality assurance
• Provisions of GMP with respect to followings � General provisions related to finished pharmaceuticals � Building, facilities and Plant Layout:
a) Basic requirements of design b) Plant layout c) Design of large scale manufacturing unit for sterile and nonsterile
products (with special reference to tablets, capsules As per Schedule M), The emphasis be also given to design of facilities & utilities
d) Design of Pilot Plant for tablets, capsules e) Equipment selection vis a vis plant design f) Heating Ventilation and Air Conditioning System (HVAC)
� Equipments � Containers & closures � Production & process control � Packaging & labeling controls � Records & reports � Documentation related to manufacturing, cleaning methods, retention samples and
records, quality control, batch release documents, distribution records, complaints and recalls.
3. Process Validation
• Regulatory basis, Terminology: validation, qualification, calibration
• Prospective process validation
• Retrospective validation
• Validation of sterilization processes (Heat & Filtration)
• Validation of tablets & capsules manufacturing processes
• Qualification of water systems
• Qualification of Air-Handling systems
• Qualification of Equipments
• Qualification of Facility
• Validation & verification of cleaning process
• Computer system validation
Recommended Study material: (Latest edition of the books should be referred)
1. How to practice GMPs; P.P.Sharma, 5th Edition, Vandhana Publications, New Delhi.
2. Pharmaceutical process validation, Bernard T. L. and Robert A. Nash, Volumes 23, Marcel Decker.
3. Good Manufacturing Practice for pharmaceuticals, Sidney H. Willing, Mercel Decker Inc.
4. Validation of Pharmaceutical Process, James Agalloco, 3rd Edition, Infroma
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Healthcare USA 5. Validation of Pharmaceutical Processes, Sterile Products, F.J.Carleton, Marcel
Dekker Inc. 6. Guidelines on cGMP & Quality of Pharmaceutical Products, S. Iyer, D.K.
Publication, Mumbai. 7. Validation in Pharmaceutical Industry (Concept, Approches & Guidelines), P.P.
Sharma, Vandhana Publications, New Delhi. 8. Good manufacturing practices for Pharmaceuticals: A plan for total quality control,
Second edition; By Sidney H. Willig. 9. Applied production and operations management; By Evans, Anderson,
Sweeney and Williams. 10. A Text of Pharmacy management, HW Tomski, Kogan Page ltd. London. 11. ISO 9000 and 14000 Series 12. Pharmaceutical Production and management by C.V.S. Subrahmanyam, Vallabh
Prakashan. 13. Pilot plants model and scale-up methods, Johnstone and Thring. 14. Chemical Engineering Plant Design, Vibrant. 15. Drug and Cosmetic Act 1940 & Rules 16. Pharmaceutical Production Facilities, design and applications, by G.C. Cole, Taylor and
Francis. 17. Pharmaceutical Project Management, T.Kennedy, Vol 86, Marcel Dekker, NY 18. Theory and Practice of Industrial Pharmacy, Liberman, Lachman 19. Pharmaceutical production facilities: design and applications. Cole,Graham 20. Safety assessment for pharmaceuticals, Gad,Shayne. 21. From Bench to Pilot plant:Process research in thepharmaceutical industries,Mehdi
Nafissi,John a Ragan,Keith M Devries. 22. Pharmaceutical Process Scale-up, Michael LevinPharmaceutical Process engineering, David
Ganderton & Anthony Hickey
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M. Pharm. [Pharmaceutics (Drug Regulatory Affairs)] Programme
SYLLABI
(Semester – 2)
CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY
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BIOSTATISTICS (PH823)
(Theory & Practical)
Credits: 2: Theory Contact hrs per week: 2: Theory 2: Practical 4: Practical
Objective of the Course:
• To acquaint students with various Statistical Techniques used to draw conclusions in
Experimental Research.
• To emphasize the use of these Techniques to address the problems and issues arising in the
discipline of Pharmacy and to find their solutions using Statistical Software.
Student Learning Outcomes / objectives:
• Students will able to identify, analyze and solve problems related to biostatistics using
statistical software.
Instructional Method and Pedagogy:
• Lectures will be taken in class room with the aid of multi-media presentations / black board
or mix of both.
• Assignments based on the course content will be given at the end of the chapter.
• Assignment should be submitted to the respective course teacher within the given time limit.
Outline of the course:
Sr.
No.
Title of the unit Minimum
number of
hours
Approx.
Weightage
%
1. Basics of Probability Distribution 6 20
2. Statistical Computing & Data Management 4 15
3. Principles of Statistical Inference 5 15
4. Analysis of Categorical Data 6 20
5. Linear Models and Experimental Design 4 15
6. Optimization Techniques 5 15
Total 30 100%
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Detailed Syllabus (Theory):
Sr. No.
Contact Hrs.
1. Basics of Probability Distribution 6 1.1 Probability, random variables, discrete and continuous distributions. 1.2 Sampling Techniques: Simple Random Sampling, Stratified, Systematic
Cluster Sampling and Sampling distributions 1.3 Numerical simulation and graphing with SYSTAT 2. Statistical Computing & Data Management 4 2.1 Data management principles and concepts using relational database
software (Microsoft Access). 2.2 Data manipulation, descriptive analyses and interpretation using statistical
software 3. Principles of Statistical Inference 5 3.1 Key concepts of estimation, Point Estimates and Interval Estimates,
Construction of Normal-theory confidence intervals 3.2 Theory of estimation including hypothesis tests; methods of inference
based on likelihood theory, including use of Fisher information criteria, Sample size and power
3.3 Wald and score tests; introduction to distribution-free statistical methods. 4 Analysis of Categorical Data 6
4.1 Methods for contingency tables: odds ratios, relative risks, 4.2 Chi-squared tests for independence, Mantel-Haenszel methods for
stratified tables, and methods for paired data. 5 Linear Models and Experimental Design 4
5.1 Method of least squares; regression models and related statistical inference; multiple regression with matrix algebra; model construction and interpretation.
5.2 One way analysis of variance, planned versus posteriori comparisons, two way analysis of variance, Factorial experiments.
5.3 Response surface design.
6. Optimization Techniques
5
6.1 Optimization using factorial designs 6.2 composite design to estimate curvature 6.3 The simplex lattice
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Detailed Syllabus (Practicals):
Sr No.
Title of the topic
1. Comparison of two independent groups with observations measured on an ordinal, interval, or ratio scale
2. Comparison of two matched groups with observations measured on an ordinal, interval, or ratio scale
3. Comparison of two independent groups with observations measured on a dichotomous scale
4. Comparison of two matched groups with observations measured on a dichotomous scale
5. Prediction of a continuous response variable from a continuous design variable 6 Measures of association and agreement for observations measured on a nominal,
ordinal, interval, or ratio scale
7 Optimization Techniques
Recommended study materials:
1. Stanford Bolton, Charles Bon (2004), Pharmaceutical Statistics, Practical and Clinical
Applications (Fourth rev. ed) Marcel Dekker, Inc
2. Dowdy, S., and Wearden, S. (1991), Statistics for Research (2nd ed.), New York: John Wiley.
3. Freund, R. J., and Wilson, W. J. (1997), Statistical Methods (rev. ed.), San Diego, CA: Academic
Press
4. Miller, R. G., Efron, B., Brown, B. W., and Moses, L. E. (eds.) (1980), Biostatistics Casebook, New
York: John Wiley.
5. Steel, R. G. D., and Torrie, J. H. (1980), Principles and Procedures of Statistics: A Biometrical Approach
(2nd ed.), New York: McGraw-Hill.
6. Woolson, R. F. (1987), Statistical Methods for the Analysis of Biomedical Data, New York: John Wiley.
7. Wackerly DD, Mendenhall W, Scheaffer RL. Mathematical Statistics with Applications, 7th
edition, 2008, Duxbury Press, USA
8. Piantadosi S. Clinical Trials a Methodological Perspective, 2nd edition. John Wiley & Sons 2005
9. Senn S. Cross-over trials in clinical research, 2nd edition. Wiley, 2002.
10. Jennison C. and B.W. Turnbull. Group sequential methods with applications to clinical trials.
Chapman & Hall, 1999.
11. Relevant articles from journals.
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RESEARCH METHODOLOGY (PH824)
Credits: 4: Theory Contact hrs per week: 4: Theory
Objective of the Course:
To make students familiar with various established methods used in pharmaceutical research.
Student Learning Outcomes/Objectives:
At the end of the course, the student will be able to understand the hierarchy of continue research by proper fundamental methodology.
Instructional Methods and Pedagogy:
Faculty member/s shall explain in a class room using black board and multimedia projector.
Outline of the Course:
Sr. No.
Unit
Minimum No. of Contact
Hours
Approx. Weightage %
1 Research-Meaning 6 8
2 Literature survey 6 8
3 Selecting a problem and preparing Research proposals
4 6
4 Methods and tools used in research 6 8
5 Documentation 6 8
6 The Research Report Paper writing/ thesis writing
15 31
7 Presentation 8 15
8 Cost analysis of the project 4 7
9 Sources for procurement of research grants 2 4
10 Industrial-institution interaction 3 5
Total 60 100 %
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Syllabus (Theory): 1 Research:
Meaning, purpose, Types, (Educational, Clinical, Experimental, historical descriptive, Basic applied and Patent oriented Research) objective of research.
2 Literature survey: Use of Library, books and journals-Medlines-Internet, Patent Search, and reprints of articles as a source for Literature survey.
3 Selecting a problem and preparing Research proposals: 4 Methods and tools used in research:
• Qualitative studies, quantitative studies
• Simple data organization, descriptive data analysis
• Limitation & sources of Error
• Inquiries in form of Questionnaire, etc. 5 Documentation:
“How” of documentation Techniques of documentation Importance of documentation Use of computer packages in documentation.
6 The Research Report writing, Paper writing/ thesis writing: Different parts of the Research paper
• Title , Authors Name & contact details
• Abstract- statement of the problem, background and purpose and scope of research.
• Key Words
• Subject Area
• Methodology: apparatus, instrumentation & procedure.
• Results- tables, graphs, figures & statistical presentation
• Discussion : support or non support of hypothesis, practical & theoretical
• Implications • Conclusion
• Acknowledgements.
• References
• Errata
• Importance of Spell check for entire research paper
• Uses of footnotes 7 Presentation (especially for oral presentation):
Importance, types different skills, content, format of model, gestures, eye contact, facial expressions, stage-fright, volume- pitch, speed, pause & language, Visual aids & Questionnaire.
8 Cost analysis of the project: Cost incurred on raw materials, different testing procedures for the same parameter, cost of instrument utilization & cost of the clinical trials.
9 Sources for procurement of research grants: International agencies, Government and private bodies.
10 Industrial-institution interaction: Industrial projects and their feasibility reports
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Recommended study materials: (Latest edition of the books should be referred)
1. Research In Education- John V. Best, John V. Kahn 7th edition, Published by: Phi
Learning Pvt. Ltd
2. Presentation skills - Michael Hallon- Indian Society for Institute education
3. Practical Introduction to copyright.- Gavin McFarlane, Published By: Mcgraw-Hill
Inc, USA.
4. Thesis projects in Science & Engineering – Richard M. Davis. New York: St. Martin’s
Press, 1980.
5. A review of “Scientist in legal Systems”, Journal of Forensic Sciences (JOFS),21(2),1976.
6. Thesis & Assignment – Jonathan Anderson by John Wiley & Sons Inc. USA (1998).
7. Donald Menzel, Jones, Howard Mumford; Boyd, Lyle G., Writing a technical paper, J.
Chem. Edu., 1962, 39 (6), p A500
8. Effective Business Report Writing –Leland Brown, 2nd Edition, Prentice-Hall, Englewood Cliffs, New Jersey, 1963.
9. Protection of industrial Property rights- P. Das & Gokul Das.
10. Preparing for publication: A Style Book for Authors, Editors, Compilers and Typists
– King Edward Hospital Fund for London.
11. The Hindu speaks on Information Technology (Special Publication by The Hindu)
12. Manual for evaluation of industrial projects-(Prepared Jointly by United Nations Industrial Development Organization and the Industrial Development Center for Arab States).
13. Manual for the preparation of industrial feasibility studies (Newly rev. and expanded ed. W. Behrens, P.M. Hawranek, Published by United Nations Industrial Development Organization in Vienna .1991.
14. Relevant articles from journals
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DRUG REGULATORY AFFAIRS-II (PH881.04) (Theory & Practical)
Credits: 3: Theory Contact hrs per week: 3: Theory
2: Seminar 2: Seminar 1: Practical 2: Practical
Objectives of the course:
• To understand the basics and documentations of the USFDA.
• To learn about the ICH guidelines for quality, safety and efficacy.
Students learning outcomes/objectives:
• To be able to prepare documentation w.r.t. the USFDA and ICH guidelines.
Instructional Methods and Pedagogy:
• Lectures and Class discussions
• Presentation on the case related to the course.
• Through discussion in a class-room and preparing case studies.
Outline of the course:
No. Unit Minimum no. of Contact Hours.
Aprrox. Weightage %
1 Introduction to US FDA 7 16
2 US FDA -I 9 20
3 US FDA -II 7 16
4 International Conference On Harmonisation 5 12
5 ICH guidelines on quality 7 14
6 ICH guidelines on efficacy 4 9 7 ICH Guidelines on safety 6 13
Total 45 100%
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Detailed Syllabus:
1. Introduction to US FDA: A detailed study of Federal Food, Drugs and Cosmetics Act of USA, restricted to human drugs, cosmetics and biotechnological products, with special emphasis on:
• Organization and functions of FDA, including historical developments.
• General definitions.
• Adulterated & misbranded drugs/cosmetics/biotechnological products.
• OTC drugs, Orphan drugs, Orange Book and Fast Track Products.
• General penalties as applicable to drugs, cosmetics and biotechnological products.
2. US FDA-I: A detailed study of Federal Food, Drugs and Cosmetics Act of USA,
restricted to human drugs, cosmetics and biotechnological products, with special emphasis on:
• General drug approval process.
• Investigational New Drug application.
• New Drug Application and BLA.
• ANDA.
• SNDA, SUPAC and BACPAC.
• Post marketing surveillance.
3. US FDA- II: A detailed study of Federal Food, Drugs and Cosmetics Act of USA, restricted to human drugs, cosmetics and biotechnological products, with special emphasis on :
• Labelling and advertising requirements for drugs, cosmetics and biotechnological products.
• Introduction to environmental protection laws, as applicable to drugs, cosmetics and biotechnological products, including EPA and OSHA.
• Common Technical Document and Drug Master Files.
• Factory Inspection.
4. International Conference On Harmonisation Of Technical Requirements
For Registration of Pharmaceuticals For Human Use: History, structure and process for hormonisation.
5. ICH guidelines on quality: Stability Testing of New Drug Substances and
Products Stability Testing : Photostability Testing of New Drug Substances and Products, Stability Testing for New Dosage Forms, Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products, Evaluation of Stability Data, Impurities in New Drug Substances, Impurities in New Drug Products, Impurities: Guideline for Residual Solvents,
6. ICH guidelines on efficacy: ICH guidelines on clinical trial and Good Clinical Practice
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7. ICH Guidelines on safety: Carcinogenicity Studies - Need for Carcinogenicity Studies of Pharmaceuticals and Testing for Carcinogenicity of Pharmaceuticals. Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals.
Practicals / Assignments / Case studies: To illustrate the topics included under theory.
Recommended books: (Latest edition of the books should be referred)
1. Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices By John J. Tobin and Gary Walsh
2. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition by Douglas J. Pisano and David S. Mantus
3. Good Drug Regulatory Practices: A Regulatory Affairs Quality Manual (Good Drug Development Series, Vol 1) by Helene I. Dumitriu
4. Encyclopedia of Pharmaceutical Technology, Jasmes Swarbrick and James C. Boylan, Marcel Dekker Inc., New York.
5. Guidelines for Developing National Drug Policies; WHO Publications, 1998. 6. Export Marketing by Cherian and Parab; Himalaya Publishing House, Delhi
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DRUG REGULATORY AFFAIRS–III (PH 881.05) (Theory & Practical)
Credits: 3: Theory Contact hrs per week: 3: Theory 1.5: Practical 3: Practicals
Objectives of the course:
• To provide a detailed view of the pharmaceutical regulations in EU, WHO and Rest of the World.
• To integrate aspects of licensing, auditing and documentation of the pharmaceutical drug product manufacturing.
Students learning outcomes/objectives:
• To develop the ability to effectively apply knowledge of law related to the pharmaceutical industries and certification of the licensing and documentation.
• He/She should be able to explain and prepare documentation for the application of the drug products in EU and other countries
Instructional Methods and Pedagogy:
Through lectures, discussion in a class-room.
Outline of the course:
No. Unit Minimum no. of Contact Hours.
Aprrox. Weightage %
1
Drug regulatory authorities in European Union (EU) with special reference to EMA and UKMHRA
12
26
2 The WHO Guidelines 10 22
3 Guidelines for Rest of World (ROW) 12 26
4 Auditing of manufacturing facilities 4 9
5 Status of pharmaceutical industry 3 8
6 Development of orphan drug 4 9
Total 45 100%
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Detailed Syllabus:
1. Drug regulatory authorities in European Union (EU) with special reference to EMA and UKMHRA:
• Introduction, Organization and General Guidelines.
• Regulatory consideration for pre-clinical testing and clinical testing in EU.
• Registration application for marketing approval (IND, NDA, ANDA) in EU, Drug Master Files in EU.
• Regulatory considerations for manufacturing, packaging and labelling of pharmaceuticals in EU.
2. The WHO Guidelines:
• The WHO Guidelines and their relevance in international registration. • The WHO certification scheme on the quality of pharmaceutical product
moving in international commerce.
• Introduction to Pharmacovigilance.
• Plant Layout as per WHO Guidelines.
3. Guidelines for Rest of World (ROW): African countries (MCC), Australia (TGA), Brazil (ANVISA), Japan, CIS countries, Gulf countries etc.
4. Auditing of manufacturing facilities by International regulatory agencies.
The ISO 9000 series of quality systems standards.
5. Status of pharmaceutical industry with special reference to post GATT scenario. Project planning and implementation.
6. Development of orphan drug: Introduction, Designation process, tax credit,
PDUFA (Prescription drug user fee act) and Orphan products development, Clinical trial design for rare disease treatment.
Practicals / Assignments / Case studies: To illustrate the topics included under theory.
Recommended Study material: (Latest edition of the books should be referred) 1. Guidelines for Developing National Drug Policies; WHO Publications, 1998. 2. Export Marketing by Cherian and Parab; Himalaya Publishing House, Delhi 3. The Pharmaceutical Regulatory Process, 2nd ed. – Ira R. Berry, Robert P. Martin
Medical Product Regulatory Affairs: Pharmaceutical , Diagnostics, Medical Devices John J. Tobin and Gary Walsh
4. Good Drug Regulatory Practices: a Regulatory Affairs Quality Manual (Good Drug Development Series) – Helene I. Dumitriu.
5. OPPI-Quality Assurance. 6. Quality Assurance of Pharmaceuticals–A Compendium of Guidelines and Related
Materials, Vol.–1; WHO Publications. 7. Good Manufacturing Practices for Pharmaceuticals-A Plan for Total Quality Control by
Sidney H. Willing & James R Stoker. (Drugs & Pharm. Sciences) Vol. 78; Marcel Dekker Inc.
8. Original laws published by Govt. of India. 9. Text Book of Forensic Pharmacy by Mithal B. M.; Vallabh Prakashan, New Delhi. 10. Laws of Drugs in India by Hussain. 11. Guidelines for Developing National Drug Policies; WHO Publications, 1998. 12. Relevant articles from journals.
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PHARMACEUTICAL FORMULATIONS & ADVANCED TECHNOLOGY (PH 881.06) (Theory & Practical)
Credits: 3: Theory Contact hrs per week: 3: Theory 1.5: Practical 3: Practical 2: Seminar 2: Seminar
Objectives of the course:
• To understand the principles of formulation technology, processing and manufacturing of Pharmaceutical products on both small and large scale.
• To provide an overview w.r.t. recent advances in manufacturing of sterile and non- sterile pharmaceutical products.
Students learning outcomes/objectives:
• To be able to review the list of ingredients in a commercial Pharmaceutical product and understand the functionality of each ingredient.
Instructional Methods and Pedagogy:
• Lectures and Class discussions.
• Presentation on a case related to the course.
• Visit to Pharmaceutical Industry to visualize packaging technology. Outline of the course: No. Unit Minimum no. of
Contact Hours. Aprrox.
Weightage %
1
Formulation, manufacturing, manufacturing flowcharts, in process-quality control tests and finished product quality control tests Scale Up and SUPAC guidelines for following dosage forms
12
26
2 Formulation of Immediate Release (IR) dosage forms
5 12
3
Formulation of Sustained Release (SR) and Controlled Release (CR) dosage forms
10
22
4 Advance Sterile Product M a n u f a c t u r i n g Technology
9 20
5 Advance Non-Sterile Solid Product Manufacturing Technology
9 20
Total 45 100%
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Detailed Syllabus: Part I: Pharmaceutical Formulations 1. Formulation, manufacturing, manufacturing flowcharts, in process-quality control tests, finished product quality control tests, Scale Up and SUPAC guidelines for following dosage forms:
• Tablets (compressed & coated)
• Capsules (Hard & Soft)
• Semisolids (ointment & creams)
• Solution
• Suspension and Emulsion
• Sterile dosage forms
2. Formulation of Immediate Release (IR) dosage forms:
• Fast dissolving tablets
• Effervescent tablets
• Mouth dissolving Strips / Films
3. Formulation of Sustained Release (SR) and Controlled Release (CR) dosage forms: Physicochemical and Biological factors influencing design of dissolution controlled systems, Diffusion controlled systems, Bioerodible systems, Osmotically controlled systems, Ion Exchange systems.
Part II: Recent Advances in Pharmaceutical Technology
4. Advance Sterile Product M a n u f a c t u r i n g Technology : Process Automation in Pharmaceutical Industry with specific reference to manufacturing of sterile semisolids, LVP & SVP, Monitoring of Parenteral manufacturing facility, Cleaning in Place (CIP), Sterilization in Place (SIP), Prefilled Syringe, Powdered Jet, Needle Free Injections, and Form Fill Seal Technology (FFS), Lyophilization Technology: Principles, process, equipments 5. Advance Non-Sterile Solid Product Manufacturing Technology: Process Automation in Pharmaceutical Industry with specific reference to manufacturing of tablets and coated products, Improved Tablet Production: Tablet production process, granulation and pelletization equipments, continuous and batch mixing, rapid mixing granulators, rota granulators, spheronizers and marumerisers, and other specialized granulation and drying equipments. Problems encountered. Coating Technology: Process, equipments, particle coating, fluidized bed coating, application techniques. Problems encountered.
Practicals: To illustrate the topics included under theory.
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Recommended Study material: (Latest edition of the books should be referred) 1. Pharmaceutical Production Facilities, design and applications, by G.C. Cole, Taylor
and Francis. 2. Theory and Practice of Industrial Pharmacy, Liberman, Lachman 3. Pharmaceutical Process engineering, David Ganderton & Anthony Hickey
4. Remington: The Science and Practice of Pharmacy , Gennaro A R, 20th
Edition, Vol: I & II, Lippincott Williams &Wilkins, Philadelphia, USA
5. Modern Pharmaceutics, G.S. Banker and C.T. Rhodes, Marcel Dekker, NY. 6. Pharmaceutical dissolution testing, U.V. Banaker, Marcel Dekker, Inc., New York. 7. Pharmaceutical Dosage Forms: Tablets, Vol. I, II &III, Lierberman H. A. and Leon
Lachman, Marcel Dekker, New York 8. Pharmaceutical Dosage Forms: Parenteral, Vol. I, II &III, Lierberman H. A. and Leon
Lachman, Marcel Dekker, New York. 9. Pharmaceutical Dosage Forms: Disperse system, Vol. I, II &III, Lierberman H. A. and
Leon Lachman, Marcel Dekker, New York 10. Pharmaceutics The Science of Dosage form Design, Aulton M E, Churchill
Livingstone, London 11. Encyclopedia of Pharmaceutical Technology, 2nd Edition, James swarbrick, Marcel
Dekker, USA. 12. Progress in Controlled and Novel Delivery Systems, N.K. Jain, CBS Publishers &
Distributors, New Delhi. 13. Indian Pharmacopoeia 2007, The Indian Pharmacopoeial Commission, India. 14. The Pharmaceutical Codex, 12th Edition, Walter Lund, The Pharmaceutical Press,
London. 15. USP NF 2004, Asian Edition, United State Pharmacopoeial Convention INC., USA. 16. British Pharmacopoeia 2004, British Pharmacopoeial Commission, London. 17. Handbook of Pharmaceutical Controlled Release Technology, Donald L. Wise, Marcel
Dekker, USA. 18. Ansel’s Pharmaceutical Dosage Form & Drug Delivery System, 8th Edition, L.U. Allen
and H.C. Ansel, Indian Edition, Lippincott Williams &Wilkins, Philadelphia, USA.
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M. Pharm. [Pharmaceutics (Drug Regulatory Affairs)] Programme
SYLLABI
(Semester – 3)
CHAROTAR UNIVERSITY OF SCIENCE AND TECHNOLOGY
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Page 45 of 46
INTELLECTUAL PROPERTY RIGHTS (PH922) Credits: 4: Theory Contact hrs per week: 4: Theory Objectives of the course:
• To explore Intellectual Property Rights and practical aspects related to patenting Students learning outcomes/objectives:
• To get familiar with Intellectual Property Rights with emphasis on the Patent System. Instructional Methods and Pedagogy:
• The course employs lectures and class discussions. It also includes presentation by students on a specific topic assigned to them by the faculty
Outline of the course:
No. Unit Minimum no. of Contact Hours.
Aprrox. Weightage %
1 Intellectual Property Concepts 10 17
2 IPR and Pharmaceutical Research 10 17
3 Practical aspect of patenting 12 20
4 IPR related treaties 10 17
5 Case Study 18 29
Total 60 100%
Detailed Syllabus Theory:
1. Intellectual Property Concepts:
• Concept of property, conventional property Vs Intellectual Property
• Basic aspect of the 8 different IPR mechanism Viz. Patents, Copyright, trademark, industrial design, layout design of integrated circuits, geographical indicators, plant varieties & trade secrets.
• WTO, TRIPS and TRIMS.
2. IPR and Pharmaceutical Research:
• Benefits of IPRs to improve the quality of research work • Strategies for avoiding research duplications, infringements
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3. Practical aspect of patenting: • Indian patent act and its recent amendment with respect to following aspect
o Patentable and non-patentable inventions. o Essential criteria for filing a patent. o Filling a patent in India and abroad o Drafting of patent application
• Patenting: Regional routes & national routes.
• Introduction to World Intellectual Property Organization. (WIPO)
• Commercialization of patent: Need for Commercialization of research and role of IPRs in research Commercialization.
• Bayh Dole Act and Technology Transfer.
• Benefit/Disadvantages of patenting to the society • Patent Exemptions.
4. IPR related treaties: 1. Patent co-operative treaty 2. Budapest treaty
5. Case Study Recommended Study material: (Latest edition of the books should be referred)
1. IPR Handbook for Pharma Students and Researchers, Parikshit Bansal, Pharma Book Syndicate, Hyderabad.
2. Patents, N. R. Subbaram, Pharma Book Syndicate, Hyderabad. 3. Relevant articles from journals. 4. www.pat2pdf.org 5. www.patentstorm.us 6. www.freepatentsonline.com 7. http://www.wipo.int/pctdb/en/ 8. www.espacenet.com
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