The Path from Biomarker Discovery to Regulatory Qualification
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.
What we think about matters. Our thoughts inspire, guide, and control our actions. Yet, we often focus more upon eliminating bad behavior than rejecting bad thoughts. Our Lord Jesus places priority on cleansing our inner nature before addressing outward actions (Mt. 23:26). This book is written to help Christians focus on their thought life as a…
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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