International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences

International regulatory agencies have developed recommendations and guidances for bioequivalence approaches of orally inhaled drug products (OIDPs) for local action. The objective of this article is to discuss the similarities and differences among these approaches used by international regulatory...

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發表在:AAPS J
Main Authors: Lu, Dongmei, Lee, Sau L., Lionberger, Robert A., Choi, Stephanie, Adams, Wallace, Caramenico, Hoainhon N., Chowdhury, Badrul A., Conner, Dale P., Katial, Rohit, Limb, Susan, Peters, John R., Yu, Lawrence, Seymour, Sally, Li, Bing V.
格式: Artigo
語言:Inglês
出版: Springer US 2015
主題:
Review Article
在線閱讀:https://ncbi.nlm.nih.gov/pmc/articles/PMC4406956/
https://ncbi.nlm.nih.gov/pubmed/25758352
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-015-9733-9
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