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Bioequivalence of Oral Products and the Biopharmaceutics Classification System: Science, Regulation, and Public Policy

The demonstration of bioequivalence (BE) is an essential requirement for ensuring that patients receive a product that performs as indicated by the label. The BE standard for a particular product is set by its innovator, and this standard must subsequently be matched by generic drug products. The Bi...

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Bibliografski detalji
Glavni autori: Amidon, KS, Langguth, P, Lennernäs, H, Yu, L, Amidon, GL
Format: Artigo
Jezik:Inglês
Izdano: 2011
Teme:
Online pristup:https://ncbi.nlm.nih.gov/pmc/articles/PMC3228645/
https://ncbi.nlm.nih.gov/pubmed/21775984
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1038/clpt.2011.109
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