Developing Clinically Relevant Dissolution Specifications for Oral Drug Products-Industrial and Regulatory Perspectives.

McAllister, Mark; Flanagan, Talia; Boon, Karin; Pepin, Xavier; Tistaert, Christophe; Jamei, Masoud; Abend, Andreas; Kotzagiorgis, Evangelos; Mackie, Claire

McAllister, Mark; Flanagan, Talia; Boon, Karin; Pepin, Xavier; Tistaert, Christophe; Jamei, Masoud; Abend, Andreas; Kotzagiorgis, Evangelos; Mackie, Claire.

Afiliación

McAllister M; Pfizer PGRD, Sandwich CT13 9NJ, UK.
Flanagan T; AstraZeneca UK Limited, Macclesfield SK10 2NA, UK.
Boon K; UCB Pharma SA, 1420 Braine l'Alleud, Belgium.
Pepin X; Licensing Division, MHRA, London E14 4PU, UK.
Tistaert C; AstraZeneca UK Limited, Macclesfield SK10 2NA, UK.
Jamei M; Janssen Research and Development, 2340 Beerse, Belgium.
Abend A; Certara UK, Simcyp Division, Sheffield S1 2BJ, UK.
Kotzagiorgis E; Merck & Co., Inc., West Point, PA 19486, USA.
Mackie C; European Medicines Agency, 1083 HS Amsterdam, The Netherlands.

Pharmaceutics ; 12(1)2019 Dec 23.

Article en En | MEDLINE | ID: mdl-31878006

Palabras clave

PBBM; biorelevant dissolution; clinically relevant dissolution specifications; drug products; oral; product performance

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Qualitative_research Idioma: En Revista: Pharmaceutics Año: 2019 Tipo del documento: Article País de afiliación: Reino Unido

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