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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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Detalhes bibliográficos
Publicado no:Exp Biol Med (Maywood)
Main Authors: Sauer, John-Michael, Porter, Amy C
Formato: Artigo
Idioma:Inglês
Publicado em: SAGE Publications 2017
Assuntos:
Acesso em linha: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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