Integration of Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy into Model-Informed Dose Selection in Oncology First-in-Human Study: A Case of Roblitinib (FGF401).

Wilbaux, Mélanie; Yang, Shu; Jullion, Astrid; Demanse, David; Porta, Diana Graus; Myers, Andrea; Meille, Christophe; Gu, Yi

Wilbaux, Mélanie; Yang, Shu; Jullion, Astrid; Demanse, David; Porta, Diana Graus; Myers, Andrea; Meille, Christophe; Gu, Yi.

Afiliação

Wilbaux M; Pharmacometrics, Novartis, Basel, Switzerland.
Yang S; Pharmacometrics, Novartis, East Hanover, New Jersey, USA.
Jullion A; Early Development Analytics, Novartis, Basel, Switzerland.
Demanse D; Early Development Analytics, Novartis, Basel, Switzerland.
Porta DG; Oncology, Novartis Institutes for Biomedical Research, Basel, Switzerland.
Myers A; Global Drug Development, Novartis, East Hanover, New Jersey, USA.
Meille C; Early Development Analytics, Novartis, Basel, Switzerland.
Gu Y; Pharmacokinetic Sciences, Translational Medicine, Novartis, Cambridge, Massachusetts, USA.

Clin Pharmacol Ther ; 112(6): 1329-1339, 2022 12.

Article em En | MEDLINE | ID: mdl-36131557

Assuntos

Piperazinas; Piridinas; Humanos; Piperazinas/farmacologia; Simulação por Computador; Alanina Transaminase; Modelos Biológicos; Relação Dose-Resposta a Droga

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Piperazinas / Piridinas Tipo de estudo: Prognostic_studies Limite: Humans Idioma: En Revista: Clin Pharmacol Ther Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Suíça

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