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BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements
The Biopharmaceutics Classification System (BCS), based on aqueous solubility and intestinal permeability, has enjoyed wide use since 1995 as a mechanism for waiving in vivo bioavailability and bioequivalence studies. In 2000, the US-FDA was the first regulatory agency to publish guidance for indust...
Wedi'i Gadw mewn:
| Cyhoeddwyd yn: | AAPS J |
|---|---|
| Prif Awduron: | , , , |
| Fformat: | Artigo |
| Iaith: | Inglês |
| Cyhoeddwyd: |
Springer US
2016
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| Pynciau: | |
| Mynediad Ar-lein: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5256598/ https://ncbi.nlm.nih.gov/pubmed/26943914 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-016-9877-2 |
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