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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...
Enregistré dans:
| Publié dans: | AAPS J |
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| Auteurs principaux: | , |
| Format: | Artigo |
| Langue: | Inglês |
| Publié: |
Springer US
2015
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| Sujets: | |
| Accès en ligne: | 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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