Application of Clinical Pharmacology Principles in Drug Development of Modified-Release Products: Leveraging Exposure-Response Information to Support Approval.

AbuAsal, Bilal S; Hamed, Salaheldin S; Ahmed, Mariam A; Al-Mansour, Lana; Uppoor, Ramana; Mehta, Mehul

AbuAsal, Bilal S; Hamed, Salaheldin S; Ahmed, Mariam A; Al-Mansour, Lana; Uppoor, Ramana; Mehta, Mehul.

Afiliação

AbuAsal BS; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Hamed SS; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Ahmed MA; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Al-Mansour L; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Uppoor R; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Mehta M; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

J Clin Pharmacol ; 60(11): 1441-1452, 2020 11.

Article em En | MEDLINE | ID: mdl-32453882

Assuntos

Preparações de Ação Retardada/farmacocinética; Aprovação de Drogas/métodos; Desenvolvimento de Medicamentos; Farmacologia Clínica/métodos; Ensaios Clínicos como Assunto; Bases de Dados Factuais; Preparações de Ação Retardada/efeitos adversos; Relação Dose-Resposta a Droga; Humanos; Equivalência Terapêutica; Estados Unidos; United States Food and Drug Administration

Palavras-chave

bioequivalence; exposure response; extended release; modified release

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Farmacologia Clínica / Aprovação de Drogas / Preparações de Ação Retardada / Desenvolvimento de Medicamentos Tipo de estudo: Prognostic_studies Limite: Humans País como assunto: America do norte Idioma: En Ano de publicação: 2020 Tipo de documento: Article

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