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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Veröffentlicht in:AAPS J
Hauptverfasser: 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.
Format: Artigo
Sprache:Inglês
Veröffentlicht: Springer US 2015
Schlagworte:
Review Article
Online Zugang: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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