A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products.

Muselík, Jan; Komersová, Alena; Kubová, Katerina; Matzick, Kevin; Skalická, Barbora

Muselík, Jan; Komersová, Alena; Kubová, Katerina; Matzick, Kevin; Skalická, Barbora.

Afiliación

Muselík J; Department of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University, Palackého tr. 1, 612 00 Brno, Czech Republic.
Komersová A; Department of Physical Chemistry, Faculty of Chemical Technology, University of Pardubice, Studentská 573, 532 10 Pardubice, Czech Republic.
Kubová K; Department of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University, Palackého tr. 1, 612 00 Brno, Czech Republic.
Matzick K; Department of Physical Chemistry, Faculty of Chemical Technology, University of Pardubice, Studentská 573, 532 10 Pardubice, Czech Republic.
Skalická B; Department of Physical Chemistry, Faculty of Chemical Technology, University of Pardubice, Studentská 573, 532 10 Pardubice, Czech Republic.

Pharmaceutics ; 13(10)2021 Oct 15.

Article en En | MEDLINE | ID: mdl-34683995

Palabras clave

EMA and FDA strategy; dissolution profile comparison; drug dissolution

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Guideline / Prognostic_studies Idioma: En Revista: Pharmaceutics Año: 2021 Tipo del documento: Article País de afiliación: República Checa Pais de publicación: Suiza

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