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Drug Development process

By

Snigdhadeb Dey

Tamara Ray

Supervisor : Dr Karabee ChatterjeeApollo Gleneagles, Kolkata

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Drugs

Broadly speaking, is any substance that, when absorbed into the body of aliving organism, alters normal bodily function.

In pharmacology, a drug is "a chemical substance used in the treatment,

cure, prevention, or diagnosis of disease or used to otherwise enhance

physical or mental well-being. Drugs may be prescribed for a limitedduration, or on a regular basis for chronic disorders.

http://en.wikipedia.org/wiki/Pharmacologyhttp://en.wikipedia.org/wiki/Chemicalhttp://en.wikipedia.org/wiki/Chronic_(medicine)http://en.wikipedia.org/wiki/Chronic_(medicine)http://en.wikipedia.org/wiki/Chemicalhttp://en.wikipedia.org/wiki/Pharmacology

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Drug Development

In a nutshell

Drug

Discovery

Pre-Clinical

Animal Testing

Human Clinical Trials

Approval

Process

Post Marketing

Surveillance

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Drug Discovery

Program selection-

Identification of the problem-disease

A single continuous layer of flat-to-cubodial mesothelial cells covering the ovary is

considered to be the tissue of origin of EOCs

(Epithelial Ovarian cancer)

OSE EOC?

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LEAD

Lead is a compound which from a series ofcompounds have some desirable biologicalactivity

First foothold of the drug Compound library- collection of compounds,

variety or diversity of the compounds will vary

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Discovery- Lead,Compound Library, Combichem

pGlu

His

Ser

Tyr(His)

Gly

Leu(Trp)

Arg(Tyr)

Pro

Gly-NH

Trp

Lead optimization

Compound

library

Combichem

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Preclinical Testing

In-vitro cell studies

Cell migration assays

In-vivo drug validation studies

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depending on the

design, technology, and performance of your device, we may recommend additional pre-clinical

evaluation.

A. Test ProtocolsWe recommend the test protocol describe clearly defined test objectives and a rationale in

support of your belief that the endpoints and pass/fail criteria are meaningful and clinically

relevant.

B. Test Methods and ConditionsWe recommend you provide a clear description of the test methodology and actual test

conditions. We recommend you conduct pre-clinical testing, where appropriate and feasible,

in an environment that simulates actual clinical conditions.

C. Actual Device EvaluatedWe recommend you indicate whether you used a neurothrombectomy device fabricated by

representative manufacturing process. Otherwise, we recommend you submit a rationale

explaining your belief that the device you used in testing will provide a sufficient assessmentof the final finished device.

D. Statistical AnalysisWe recommend you provide your sample size justification. We recommend the results you

report include, where appropriate:

number of samples

range of values

mean

standard deviation

95% confidence interval.We also recommend you provide a probability measure that is indicative of the statistical

significance of any comparisons you make to other devices or control groups.

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IND CDER offers a Pre-Investigational New Drug Application (IND) Consultation Program6 to foster early

communications between sponsors and new drug review divisions in order to provide guidance onthe data necessary to warrant IND submission.

Animal pharmacology, toxicology studies

Evidences of previous exposure/use on human

Manufacturing details

Clinical protocol and investigator information

Lets the FDA understand the level of initial exposure

Must be updated on annual basis

Amendments can be filed anytime

Sites can be contacted, timelines may become an issue

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/Overview/default.htmhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/Overview/default.htmhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/Overview/default.htmhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/Overview/default.htm

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Human Clinical Trials

Phase IV

Post Marketing Trials

Phase III

Confirmatory

trials

Phase II

Explanatory

Trialsefficacy and safety.

Phase I

Human/Clinical Pharmacology

Immunogenic PotencyMTD

P

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Healthy volunteers(15-30)using clinical, physiologicaland biochemicalobservations. At least 2subjects should be used oneach dose.

MTD,Pharmaodynamics,

pharmacokinetics, adverse

reactions of the Study drug

Cytotoxic drugs are studied inpatients

Investigators requiresspecialized facilities for theconduction of the trials

Patient pool = homogenouspopulation selected by (