Biopharmaceutics Classification System-Based Biowaivers for Generic Oncology Drug Products: Case Studies

Establishing bioequivalence (BE) of drugs indicated to treat cancer poses special challenges. For ethical reasons, often, the studies need to be conducted in cancer patients rather than in healthy volunteers, especially when the drug is cytotoxic. The Biopharmaceutics Classification System (BCS) int...

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Detaylı Bibliyografya
Yayımlandı:AAPS PharmSciTech
Asıl Yazarlar: Tampal, Nilufer, Mandula, Haritha, Zhang, Hongling, Li, Bing V., Nguyen, Hoainhon, Conner, Dale P.
Materyal Türü: Artigo
Dil:Inglês
Baskı/Yayın Bilgisi: Springer US 2014
Konular:
Review Article
Online Erişim:https://ncbi.nlm.nih.gov/pmc/articles/PMC4309807/
https://ncbi.nlm.nih.gov/pubmed/25245330
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12249-014-0195-7
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