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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Dades bibliogràfiques
Publicat a:AAPS J
Autors principals: 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
Idioma:Inglês
Publicat: Springer US 2015
Matèries:
Review Article
Accés en línia: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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