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Influence of Drug Properties and Formulation on In Vitro Drug Release and Biowaiver Regulation of Oral Extended Release Dosage Forms
Bioequivalence (BE) studies are often required to ensure therapeutic equivalence for major product and manufacturing changes. Waiver of a BE study (biowaiver) is highly desired for such changes. Current regulatory guidelines allow for biowaiver of proportionally similar lower strengths of an extende...
Zapisane w:
| Wydane w: | AAPS J |
|---|---|
| Główni autorzy: | , , , |
| Format: | Artigo |
| Język: | Inglês |
| Wydane: |
Springer US
2016
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| Hasła przedmiotowe: | |
| Dostęp online: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4779102/ https://ncbi.nlm.nih.gov/pubmed/26769249 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-015-9861-2 |
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