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Author:   Tom Brody (Contract Researcher, Baker Hostetler, San Francisco, CA, USA)
Publisher:   Elsevier Science Publishing Co Inc
Imprint:   Academic Press Inc
Edition:   2nd edition
Dimensions:   Width: 19.10cm , Height: 4.60cm , Length: 23.50cm
Weight:   2.740kg
ISBN:  

9780128042175

ISBN 10:   0128042176
Pages:   896
Publication Date:   14 March 2016
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   Temporarily unavailable  
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Table of Contents

Introduction The Origins of DrugsIntroduction to Clinical Trial DesignRun-in PeriodInclusion/Exclusion Criteria, Stratification and Subgroups - Part IInclusion and Stratification Criteria - Part IIRandomization, Allocation, and BindingIntent to Treat Analysis vs. Per Protocol AnalysisBiostatistics - Part IBiostatistics - Part IIIntroduction to Endpoints for Clinical Trials in PharmacologyEndpoints in Clinical Trials on Solid Tumors - Objective ResponseOncology Endpoints: Overall Survival and Profession-Free SurvivalOncology Endpoints: Time to ProgressionOncology Endpoint: Disease-Free SurvivalOncology Endpoint: Time to Distant MetastasisNeoadjuvant Therapy vs. Adjuvant TherapyHematological CancersBiomarkers and Personalized MedicineEndpoints in Immune DiseasesEndpoints in Clinical Trials on InfectionsHealth-Related Quality of LifeHealth-Related Quality of Life Instruments for Immune DisordersHealth-Related Quality of Life Instruments and InfectionsDrug SafetyMechanisms of Action, Part IMechanisms of Action, Part II - CancerMechanisms of Action, Part III - Immune Disorders Mechanisms of Action, Part IV- InfectionsConsent FormsPackage InsertsRegulatory ApprovalPatents

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Author Information

Dr. Tom Brody received his PhD from the University of California at Berkeley in 1980, and conducted postdoctoral research at University of Wisconsin-Madison and also at U.C. Berkeley. His 20 research publications concern the metabolism and pharmacology of folates, cloning an anti-cancer gene (XPE gene), and the structure of an antibody (natalizumab) used for treating multiple sclerosis. The author has 15 years of pharmaceutical industry experience, acquired at Schering-Plough, Cerus Corporation, and Elan Pharmaceuticals, and has contributed to FDA submissions for the indications of multiple sclerosis, melanoma, head and neck cancer, liver cancer, pancreatic cancer, and hepatitis C. At an earlier time, he wrote two editions of Nutritional Biochemistry, published by Elsevier, Inc. The author has 16 years of training and experience in the Code of Federal regulations, as it applies to pharmaceuticals and clinical trial design.

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