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UGent - RevaKi + LO & BW KU Leuven (Leuven en Heverlee) KULAK KU Leuven campus Brugge KU Leuven campus IIW De Nayer Universiteit Gent KU Leuven campus Gent
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Home Clinical Trials

Clinical Trials

Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines

Tom Brody
Research practice and trials, Pharmaceutical sciences
Book
  • Clinical Trials - 9780128042175
€76.30
€72.49 with an Acco share
Estimated time of delivery: 5 to 15 working days
  • with an Acco share you get a discount on Acco-titles, course materials, fiction or non-fiction and office supplies.
Content

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

Specifications
Publisher
Elsevier Science Publishing Co Inc
Publication date
March 14, 2016
Pages
896
ISBN
9780128042175
Edition
2
Format
Hardback

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