Translating Molecular Biomarkers into Clinical Assays

Techniques and Applications

  • Russell Weiner
  • Marian Kelley

Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 21)

Table of contents

  1. Front Matter
    Pages i-xiii
  2. Chad Ray
    Pages 1-15
  3. R. Aleks Davis, Andrew P. Mayer, Ronald R. Bowsher
    Pages 17-25
  4. Omar F. Laterza, Xuemei Zhao
    Pages 27-35
  5. Scott T. Fountain, Paolo Vicini
    Pages 37-46
  6. Michael P. Sullivan
    Pages 99-113
  7. Manjula P. Reddy, Amy Kate Sasser
    Pages 115-126
  8. Peter J. O’Brien, Tim Wyant, Virginia Litwin
    Pages 127-140
  9. Ken C N Chang, Matthew J. Marton
    Pages 163-176
  10. Marisa Dolled-Filhart, Usha Singh, Dianna Wu, K. Emancipator
    Pages 177-187
  11. Usha Singh, Marisa Dolled-Filhart, Dianna Wu
    Pages 201-210
  12. Russell Weiner, Marian Kelley
    Pages E1-E1
  13. Back Matter
    Pages 211-212

About this book


This handbook covers established and advanced techniques for biomarker analysis, such as guidelines and strategies for assay validation methods; different mathematical models that are necessary in contemporary drug discovery and development; and evaluation of new cytometry methods. Expertly curated by two practicing professionals in drug development and biotherapeutics, individual chapters are selected for novel and sound research; information is chosen based on its relevance to lab applications and clinical trials, such as the topic of selecting animal models for their relevancy to humans. The book is multifaceted, discussing the ethics and issues with biospecimens and providing an in-depth analysis to the differences between pre-clinical and clinical assay development. The book is an essential read for general readers who need an introduction to the history and background of biomarkers,  and it also provides critical analyses of various new validation methods for practitioners and researchers. 


Biomarker pharmacokinetics FDA bioanalysis target engagement

Editors and affiliations

  • Russell Weiner
    • 1
  • Marian Kelley
    • 2
  1. 1.Translational Biomarkers and Personalized MedicineEdisonUSA
  2. 2.MKelley Consulting LLCWest ChesterUSA

Bibliographic information