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Preclinical biomarker qualification

Biomarkers are ubiquitously used within drug development programs in both nonclinical species and in humans to assess safety and efficacy of novel compounds. To routinely apply such novel biomarkers with certainty, a well-defined data package is necessary for review and endorsement by regulatory age...

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Bibliographic Details
Published in:Exp Biol Med (Maywood)
Main Authors: Sauer, John-Michael, Porter, Amy C
Format: Artigo
Language:Inglês
Published: SAGE Publications 2017
Subjects:
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC5813870/
https://ncbi.nlm.nih.gov/pubmed/29171289
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/1535370217743949
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