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Demonstrating Comparative In Vitro Bioequivalence for Animal Drug Products Through Chemistry and Manufacturing Controls and Physicochemical Characterization: A Proposal

The assessment of in vivo bioequivalence (BE) of nonsystemically absorbed drug products has been a longstanding challenge facing drug manufacturers and regulators of human or animal health products. Typically, in situations where blood level BE studies are not feasible, clinical endpoint BE trials h...

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Detalhes bibliográficos
Publicado no:AAPS J
Main Authors: Martinez, Marilyn N., Fahmy, Raafat
Formato: Artigo
Idioma:Inglês
Publicado em: Springer US 2015
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4365090/
https://ncbi.nlm.nih.gov/pubmed/25609223
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-014-9702-8
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