A mechanistic physiologically based model to assess the effect of study design and modified physiology on formulation safe space for virtual bioequivalence of dermatological drug products.

Clarke, J F; Thakur, K; Polak, S

Clarke, J F; Thakur, K; Polak, S.

Afiliación

Clarke JF; Simcyp Division, Certara UK, Sheffield, United Kingdom.
Thakur K; Faculty of Pharmacy, Jagiellonian University Medical College, Krakow, Poland.
Polak S; Simcyp Division, Certara UK, Sheffield, United Kingdom.

Front Pharmacol ; 13: 1007496, 2022.

Article en En | MEDLINE | ID: mdl-36532731

Palabras clave

PBPK absorption model; bioequivalence; complex drug products; dermal absorption; generic drugs; safe space; topical formulations; virtual bioequivalence (VBE)

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Texto completo: 1 Base de datos: MEDLINE Tipo de estudio: Prognostic_studies Idioma: En Revista: Front Pharmacol Año: 2022 Tipo del documento: Article

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Texto completo: 1 Base de datos: MEDLINE Tipo de estudio: Prognostic_studies Idioma: En Revista: Front Pharmacol Año: 2022 Tipo del documento: Article