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Documents Surrogate Markers and its role in the Drug Development Process Aloka G. Chakravarty, Ph.D. Director,...

Slide 1Surrogate Markers and its role in the Drug Development Process Aloka G. Chakravarty, Ph.D. Director, Biologics Therapeutics Statistical Staff [email protected]

Documents Phase I Trial Designs Jud Blatchford, PhD Colorado School of Public Health January 30 th, 2013.

Slide 1Phase I Trial Designs Jud Blatchford, PhD Colorado School of Public Health January 30 th, 2013 Slide 2 Table of Contents 1.Orientation 2.Introduction 3.Components…

Documents PHYSIOLOGICAL AND LABORATORY MARKERS OF DRUG EFFECT Arthur J. Atkinson, Jr., M.D. Senior Advisor in....

Slide 1 PHYSIOLOGICAL AND LABORATORY MARKERS OF DRUG EFFECT Arthur J. Atkinson, Jr., M.D. Senior Advisor in Clinical Pharmacology Clinical Center, NIH Slide 2 USES OF BIOMARKERS…

Documents Outcomes and AEs Steven R. Cummings, MD. Outline: Outcomes Primary and secondary outcomesPrimary and...

Outcomes and AEs Steven R. Cummings, MD Outline: Outcomes Primary and secondary outcomes Surrogate markers Adverse experiences Morbone A company wants help designing a trial…

Documents Biomarkers: Physiological & Laboratory Markers of Drug Effect Janet Woodcock, M.D. Deputy...

Biomarkers: Physiological & Laboratory Markers of Drug Effect Janet Woodcock, M.D. Deputy Commissioner and Chief Medical Officer Food and Drug Administration February…

Documents Clinical Trials – Human Gonadotropin Drug Products A Regulatory Perspective Shelley R. Slaughter,....

Clinical Trials – Human Gonadotropin Drug Products A Regulatory Perspective Shelley R. Slaughter, M.D., Ph. D. Reproductive Medical Officer Team Leader Division of Reproductive…

Documents Evaluation of Clinical Benefit in Sarcomas: Modern Imaging Modalities

Evaluation of Clinical Benefit in Sarcomas: Modern Imaging Modalities Robert S. Benjamin, M.D. Department of Sarcoma Medical Oncology The SARCOMA Center Thank you for your…