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The top documents tagged [meaningful endpoint]
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meaningful endpoint
Surrogate Markers and its role in the Drug Development Process Aloka G. Chakravarty, Ph.D. Director, Biologics Therapeutics Statistical Staff
[email protected]
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230 views
Phase I Trial Designs Jud Blatchford, PhD Colorado School of Public Health January 30 th, 2013.
213 views
PHYSIOLOGICAL AND LABORATORY MARKERS OF DRUG EFFECT Arthur J. Atkinson, Jr., M.D. Senior Advisor in Clinical Pharmacology Clinical Center, NIH.
221 views
Outcomes and AEs Steven R. Cummings, MD. Outline: Outcomes Primary and secondary outcomesPrimary and secondary outcomes Surrogate markersSurrogate markers.
214 views
Biomarkers: Physiological & Laboratory Markers of Drug Effect Janet Woodcock, M.D. Deputy Commissioner and Chief Medical Officer Food and Drug Administration.
216 views
Clinical Trials – Human Gonadotropin Drug Products A Regulatory Perspective Shelley R. Slaughter, M.D., Ph. D. Reproductive Medical Officer Team Leader.
220 views
Evaluation of Clinical Benefit in Sarcomas: Modern Imaging Modalities
43 views