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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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Bibliografski detalji
Glavni autori: Benet, Leslie Z., Amidon, Gordon L., Barends, Dirk M., Lennernäs, Hans, Polli, James E., Shah, Vinod P., Stavchansky, Salomon A., Yu, Lawrence X.
Format: Artigo
Jezik:Inglês
Izdano: 2008
Teme:
Online pristup: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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