Experiences and initiatives on pharmacokinetic modeling and simulation data analysis: Perspectives from the Brazilian Health Regulatory Agency (ANVISA).

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作者： Luiza Novaes,Borges ^[1] ; Eduardo Agostinho Freitas,Fernandes ^[2] ; Érico Miroro de,Oliveira ^[3] ; Victor Gomes,Pereira ^[4] ; Andréa,Diniz ^[5]

作者单位： Pharmacokinetics and Biopharmaceutics Laboratory (PKBio), Department of Pharmacy, State University of Maringá, PR, Brazil; Brazilian Health Regulatory Agency (ANVISA), Division of Therapeutic Equivalence (CETER), Brasília, Brazil. Electronic address: luiza.borges@anvisa.gov.br. ^[1] Brazilian Health Regulatory Agency (ANVISA), Division of Therapeutic Equivalence (CETER), Brasília, Brazil. Electronic address: eduardo.fernandes@anvisa.gov.br. ^[2] Brazilian Health Regulatory Agency (ANVISA), Office of Synthetic Medicines Quality Assessment (GQMED), Brasília, Brazil. Electronic address: erico.moliveira@anvisa.gov.br. ^[3] Brazilian Health Regulatory Agency (ANVISA), Office of Synthetic Medicines Quality Assessment (GQMED), Brasília, Brazil. Electronic address: victor.pereira@anvisa.gov.br. ^[4] Pharmacokinetics and Biopharmaceutics Laboratory (PKBio), Department of Pharmacy, State University of Maringá, PR, Brazil. Electronic address: adiniz@uem.br. ^[5]

关键词 Biopharmaceutics Clinically relevant dissolution specifications MIDD Modeling and simulation PBBM Patient-centric drug development Pharmacometrics Quality by design Regulatory science

主题词人类(Humans);巴西(Brazil);模型, 生物学(Models, Biological);计算机模拟(Computer Simulation);药代动力学(Pharmacokinetics);药用制剂(Pharmaceutical Preparations);生物药学(Biopharmaceutics)

DOI 10.1016/j.yrtph.2024.105728

PMID 39442666

发布时间 2024-11-30

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