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Challenges and Opportunities to Use Biowaivers to Compare Generics in China

Biowaivers for class I drugs according to the biopharmaceutics classification system (BCS) were first introduced in 2000. The in vitro equivalence can be used to document bioequivalence between products. This study compared the in vitro dissolution behavior of two BCS class I drugs, amoxicillin and...

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Bibliographic Details
Main Authors: Zuo, Jieyu, Gao, Yuan, Bou-Chacra, Nadia, Löbenberg, Raimar
Format: Artigo
Language:Inglês
Published: Springer US 2014
Subjects:
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC4179670/
https://ncbi.nlm.nih.gov/pubmed/24848759
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12249-014-0133-8
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