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Applications of model-informed drug development (MIDD) on new drug research and development / 中国临床药理学与治疗学
Chinese Journal of Clinical Pharmacology and Therapeutics ; (12): 1-8, 2020.
Artigo em Chinês | WPRIM | ID: wpr-855907
ABSTRACT
Model-informed drug development (MIDD) refers to the application of various mathematical models in drug development, in order to facilitate the decision-making process. There have been common and mature applications of MIDD to address drug development and regulatory questions in interactional industries and advanced regulatory agencies, especially the US FDA. However, its application in innovative drug development is relatively rare in China. Representative case studies, clinical pharmacology review ex-periences, and relevant guidelines are reviewed in this article to present a preliminary discussion on the main applications of MIDD. Additionally, several suggestions for the application of MIDD in new drug development as well as general considerations for new drug registration are proposed in this paper, for the discussion or reference of industries and researchers.

Texto completo: DisponíveL Índice: WPRIM (Pacífico Ocidental) Tipo de estudo: Guia de Prática Clínica / Estudo prognóstico / Pesquisa qualitativa Idioma: Chinês Revista: Chinese Journal of Clinical Pharmacology and Therapeutics Ano de publicação: 2020 Tipo de documento: Artigo

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Texto completo: DisponíveL Índice: WPRIM (Pacífico Ocidental) Tipo de estudo: Guia de Prática Clínica / Estudo prognóstico / Pesquisa qualitativa Idioma: Chinês Revista: Chinese Journal of Clinical Pharmacology and Therapeutics Ano de publicação: 2020 Tipo de documento: Artigo