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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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Publicado en:AAPS J
Autores principales: 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.
Formato: Artigo
Lenguaje:Inglês
Publicado: Springer US 2015
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Acceso en línea: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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