Within-subject pharmacokinetic variability has a strong influence on individual exposure ratios in bioequivalence studies, hence on drug formulation interchangeability.

Lechat, Philippe; Kir, Fatma; Marquet, Pierre; Woillard, Jean-Baptiste

Lechat, Philippe; Kir, Fatma; Marquet, Pierre; Woillard, Jean-Baptiste.

Afiliação

Lechat P; Paris-cité University, Paris, France. philippe.lechat@aphp.fr.
Kir F; Pharmacology and Toxicology Department, Georges Pompidou European Hospital, Drug Evaluation unit, Agence Générale des équipements et des produits de santé (AGEPS), 7 rue du fer à moulin, 75005 Paris, Assistance Publique des Hôpitaux de Paris, France. philippe.lechat@aphp.fr.
Marquet P; Department of Pharmaceutical Technology, Faculty of Pharmacy, Hacettepe University, 06100, Ankara, Turkey.
Woillard JB; Department of Pharmaceutical Technology, Faculty of Pharmacy, Lokman Hekim University, Ankara, Turkey.

Eur J Clin Pharmacol ; 79(11): 1565-1578, 2023 Nov.

Article em En | MEDLINE | ID: mdl-37737912

Assuntos

Medicamentos Genéricos; Humanos; Equivalência Terapêutica; Composição de Medicamentos; Preparações Farmacêuticas; Estudos Cross-Over; Área Sob a Curva

Palavras-chave

Average bioequivalence; Generic drug; Individual exposure ratio; Interchangeability; Reference drug

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicamentos Genéricos Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Revista: Eur J Clin Pharmacol Ano de publicação: 2023 Tipo de documento: Article País de afiliação: França

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