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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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Dettagli Bibliografici
Autori principali: Zuo, Jieyu, Gao, Yuan, Bou-Chacra, Nadia, Löbenberg, Raimar
Natura: Artigo
Lingua:Inglês
Pubblicazione: Springer US 2014
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Accesso online: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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