BIOMARKER VALIDATION AND APPLICATION IN EARLY DRUG DEVELOPMENT: IDEA TO PROOF OF CONCEPT

Editors' Note: In 2004, Pfizer leadership sponsored the creation of a confidential “Biomarker Best Practices” document by a cross-discipline and cross-development team of experts that we would today call a “translational research team” or “advisory group.” This work was completed, and Pfizer de...

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Bibliographic Details
Published inTranslational Medicine and Drug Discovery pp. 195 - 221
Main Author Global, Pfizer
Format Book Chapter
LanguageEnglish
Published Cambridge University Press 31.01.2011
Subjects
Pharmaceuticals
Pharmaceuticals, Cosmetics & Toiletries
Online AccessGet full text

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Table of Contents:
  • 8.1 Definitions and Summary of Overarching Principles 8.2 Biomarker Validation Terminology 8.3 Stages of Biomarker Lifecycle 8.4 Why Biomarkers? 8.5 Biomarker Validation 8.6 When and How to Apply Biomarkers in Drug Development: Biomarker Development is Described for Each Stage of Drug Development