


Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and Fda and Ich Guidelines
Brody, T.
1ª Edición Diciembre 2011
Inglés
Tapa dura
672 pags
1800 gr
x x cm
ISBN 9780123919113
Editorial ACADEMIC PRESS
Recíbelo en un plazo De 7 a 10 días
Key Features
- Provides extensive coverage of the ''study schema'' and related features of study design
- Offers a ''hands-on'' reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design
- Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design
- Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials
Readership
Pharmaceutical scientists and pharmacologists, medical writers and physicians, nurses and pharmacists who plan and conduct clinical trials.
Contents
- Abbreviations
- Introduction
- The Origins of Drugs
- Study Schema
- Run-in Period
- Inclusion and Stratification, Part I
- Inclusion and Stratification, Part II
- Blinding, Randomization, and Allocation
- Placebo
- Intent to Treat Versus Per Protocol
- Statistics
- Introduction to Endpoints for Clinical Trials in Pharmacology
- Oncology Endpoint: Objective Response
- Oncology Endpoint: Overall Survival and Progression-free Survival
- Oncology Endpoint: Time to Progression
- Oncology Endpoint: Disease-free Survival
- Oncology Endpoint: Time to Distant Metastasis
- Neoadjuvant Therapy Versus Adjuvant Therapy
- Hematological Cancers
- Biomarkers and Personalized Medicine
- Endpoints for Immune Diseases
- Endpoints for Infections
- Health-related Quality of Life for Oncology
- Health-related Quality of Life for Immune Disorders
- Health-related Quality of Life and Infections
- Drug Safety
- Mechanism of Action, Part I
- Mechanism of Action, Part II: Cancer
- Mechanism of Action, Part III: Immune Diseases
- Mechanism of Action, Part IV: Infections
- Consent Forms
- Package Inserts
- Regulatory Approval
- Patents
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