Population Pharmacokinetics and Exposure-Response Modeling Analyses of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis.

Xu, Yan; Adedokun, Omoniyi J; Chan, Daphne; Hu, Chuanpu; Xu, Zhenhua; Strauss, Richard S; Hyams, Jeffrey S; Turner, Dan; Zhou, Honghui

Xu, Yan; Adedokun, Omoniyi J; Chan, Daphne; Hu, Chuanpu; Xu, Zhenhua; Strauss, Richard S; Hyams, Jeffrey S; Turner, Dan; Zhou, Honghui.

Afiliação

Xu Y; Global Clinical Pharmacology, Janssen Research & Development, LLC, Spring House, PA, USA.
Adedokun OJ; Global Clinical Pharmacology, Janssen Research & Development, LLC, Spring House, PA, USA.
Chan D; Immunology Clinical Development, Janssen Research & Development, LLC, Spring House, PA, USA.
Hu C; Global Clinical Pharmacology, Janssen Research & Development, LLC, Spring House, PA, USA.
Xu Z; Global Clinical Pharmacology, Janssen Research & Development, LLC, Spring House, PA, USA.
Strauss RS; Immunology Clinical Development, Janssen Research & Development, LLC, Spring House, PA, USA.
Hyams JS; Department of Pediatrics, University of Connecticut School of Medicine and Division of Digestive Diseases, Hepatology and Nutrition, Connecticut Children's Medical Center, Hartford, CT, USA.
Turner D; Juliet Keidan Institute of Pediatric Gastroenterology, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel.
Zhou H; Global Clinical Pharmacology, Janssen Research & Development, LLC, Spring House, PA, USA.

J Clin Pharmacol ; 59(4): 590-604, 2019 04.

Article em En | MEDLINE | ID: mdl-30536638

Assuntos

Anticorpos Monoclonais/administração & dosagem; Colite Ulcerativa/tratamento farmacológico; Fármacos Gastrointestinais/administração & dosagem; Modelos Biológicos; Adolescente; Adulto; Fatores Etários; Anticorpos Monoclonais/farmacocinética; Criança; Colite Ulcerativa/fisiopatologia; Relação Dose-Resposta a Droga; Feminino; Fármacos Gastrointestinais/farmacocinética; Meia-Vida; Humanos; Masculino; Índice de Gravidade de Doença

Palavras-chave

exposure-response; extrapolation; golimumab; pediatrics; population pharmacokinetics; ulcerative colitis

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Fármacos Gastrointestinais / Colite Ulcerativa / Modelos Biológicos / Anticorpos Monoclonais Tipo de estudo: Prognostic_studies Limite: Adolescent / Adult / Child / Female / Humans / Male Idioma: En Revista: J Clin Pharmacol Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos

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