"The Path from Biomarker Discovery to Regulatory Qualification
"is a unique guide that focuses on biomarker qualification, its
history and current regulatory settings in both the US and abroad.
This multi-contributed book provides a detailed look at the next
step to developing biomarkers for clinical use and covers overall
concepts, challenges, strategies and solutions based on the
experiences of regulatory authorities and scientists. Members of
the regulatory, pharmaceutical and biomarker development
communities will benefit the most from using this book-it is a
complete and practical guide to biomarker qualification, providing
valuable insight to an ever-evolving and important area of
regulatory science.
For complimentary access to chapter 13, "'""Classic' Biomarkers
of Liver Injury, " by John R. Senior, Associate Director for
Science, Food and Drug Administration, Silver Spring, Maryland,
USA, please visit the following site: http:
//tinyurl.com/ClassicBiomarkers
Contains a collection of experiences of different groups taking
different types of biomarkers to different levels of qualification
and provides insightful case studies of an important area of
regulatory science
Focuses on practical advice, concepts, strategies and overall
outcomes to support those working toward biomarker qualification
for clinical use
Offers a valuable resource for members of the regulatory,
pharmaceutical and biomarker development communities. "
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