Clinical trials : study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines /: study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines. (2016)

• Record Type: Book
• Further Information: Note: Tom Brody, Ph.D.
• Authors: Brody, Tom
• Contents: Introduction The Origins of Drugs Introduction to Clinical Trial Design Run-in Period Inclusion/Exclusion Criteria, Stratification and Subgroups – Part I Inclusion and Stratification Criteria – Part II Randomization, Allocation, and Binding Intent to Treat Analysis vs. Per Protocol Analysis Biostatistics – Part I Biostatistics – Part II Introduction to Endpoints for Clinical Trials in Pharmacology Endpoints in Clinical Trials on Solid Tumors – Objective Response Oncology Endpoints: Overall Survival and Profession-Free Survival Oncology Endpoints: Time to Progression Oncology Endpoint: Disease-Free Survival Oncology Endpoint: Time to Distant Metastasis Neoadjuvant Therapy vs. Adjuvant Therapy Hematological Cancers Biomarkers and Personalized Medicine Endpoints in Immune Diseases Endpoints in Clinical Trials on Infections Health-Related Quality of Life Health-Related Quality of Life Instruments for Immune Disorders Health-Related Quality of Life Instruments and Infections Drug Safety Mechanisms of Action, Part I Mechanisms of Action, Part II – Cancer Mechanisms of Action, Part III – Immune Disorders Mechanisms of Action, Part IV- Infections Consent Forms Package Inserts Regulatory Approval Patents
• Edition: Second edition
• Publisher Details: Amsterdam : Academic Press
• Publication Date: 2016
• Extent: 1 online resource, illustrations (black and white)
• Subjects: 615.50724; Clinical trials -- Design
• Languages: English
• ISBNs: 9780128042588
• Related ISBNs: 9780128042175
• Notes: Note: Includes bibliographical references and index.; Note: Description based on CIP data; item not viewed.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.