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Regulatory utility of pharmacometrics in the development and evaluation of antimicrobial agents and its recent progress in China.
Zhao, Ming; Chen, Yuancheng; Yang, Dong; Lyu, Cheng; Bian, Xingchen; Li, Xin; Qiu, Weiyi; Huang, Zhiwei; Hu, Zijian; Zhang, Jing.
Afiliación
  • Zhao M; Office of Clinical Evaluation II, Center for Drug Evaluation, National Medical Products Administration, Beijing, China.
  • Chen Y; Phase I Unit, Huashan Hospital Affiliated to Fudan University, Shanghai, China.
  • Yang D; Covance Pharmaceutical Research and Development (Beijing) Co., Ltd., Beijing, China.
  • Lyu C; Department of Translational Medicine, Clinical Development Business Unit, CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd., Shanghai, China.
  • Bian X; Institute of Antibiotics, Huashan Hospital Affiliated to Fudan University, Shanghai, China.
  • Li X; Key Laboratory of Clinical Pharmacology of Antibiotics, National Health Commission, Shanghai, China.
  • Qiu W; Institute of Antibiotics, Huashan Hospital Affiliated to Fudan University, Shanghai, China.
  • Huang Z; Key Laboratory of Clinical Pharmacology of Antibiotics, National Health Commission, Shanghai, China.
  • Hu Z; Institute of Antibiotics, Huashan Hospital Affiliated to Fudan University, Shanghai, China.
  • Zhang J; Key Laboratory of Clinical Pharmacology of Antibiotics, National Health Commission, Shanghai, China.
CPT Pharmacometrics Syst Pharmacol ; 10(12): 1466-1478, 2021 12.
Article en En | MEDLINE | ID: mdl-34651458
Pharmacometrics is an emerging science that interprets drug, disease, and trial information in a mathematical fashion to inform and facilitate efficient drug development and/or regulatory decisions. Pharmacometrics study is increasingly adopted in the regulatory review of new antimicrobial agents. We summarized the 31 antimicrobial agents approved by the US Food and Drug Administration (FDA) and the 26 antimicrobial agents approved by European Medicines Agency (EMA) from January 2001 to May 2019. We also reviewed recent examples of utilizing pharmacometrics to support antimicrobial agent's registration in China, including modeling and simulation methods, effects of internal/external factors on pharmacokinetic (PK) parameters, safety and efficacy evaluation in terms of exposure-response analysis, refinement of the wording of product labeling and package leaflet, and possible postmarketing clinical trial. Ongoing communication among regulator, academia, and industry regarding pharmacometrics is encouraged to streamline and facilitate the development of new antimicrobial agents. The industry can maximize its benefit in drug development through continued pharmacometrics education/training.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Aprobación de Drogas / Antiinfecciosos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Humans País/Región como asunto: America do norte / Asia / Europa Idioma: En Revista: CPT Pharmacometrics Syst Pharmacol Año: 2021 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Aprobación de Drogas / Antiinfecciosos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Humans País/Región como asunto: America do norte / Asia / Europa Idioma: En Revista: CPT Pharmacometrics Syst Pharmacol Año: 2021 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos