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The Use of BDDCS in Classifying the Permeability of Marketed Drugs()
We recommend that regulatory agencies add the extent of drug metabolism (i.e., ≥90% metabolized) as an alternate method in defining Class 1 marketed drugs suitable for a waiver of in vivo studies of bioequivalence. That is, ≥90% metabolized is an additional methodology that may be substituted for ≥9...
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| Autori principali: | , , , , , , , |
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| Natura: | Artigo |
| Lingua: | Inglês |
| Pubblicazione: |
2008
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| Soggetti: | |
| Accesso online: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3580995/ https://ncbi.nlm.nih.gov/pubmed/18236138 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s11095-007-9523-x |
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