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

Autor: Borges LN; 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., Fernandes EAF; Brazilian Health Regulatory Agency (ANVISA), Division of Therapeutic Equivalence (CETER), Brasília, Brazil. Electronic address: eduardo.fernandes@anvisa.gov.br., Oliveira ÉM; Brazilian Health Regulatory Agency (ANVISA), Office of Synthetic Medicines Quality Assessment (GQMED), Brasília, Brazil. Electronic address: erico.moliveira@anvisa.gov.br., Pereira VG; Brazilian Health Regulatory Agency (ANVISA), Office of Synthetic Medicines Quality Assessment (GQMED), Brasília, Brazil. Electronic address: victor.pereira@anvisa.gov.br., Diniz A; Pharmacokinetics and Biopharmaceutics Laboratory (PKBio), Department of Pharmacy, State University of Maringá, PR, Brazil. Electronic address: adiniz@uem.br.
Jazyk: angličtina
Zdroj: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 Dec; Vol. 154, pp. 105728. Date of Electronic Publication: 2024 Oct 22.
DOI: 10.1016/j.yrtph.2024.105728
Abstrakt: The landscape of drug product development and regulatory sciences is evolving, driven by the increasing application of systems thinking and modeling and simulation (M&S) techniques, especially from a biopharmaceutics perspective. Patient-centric quality standards can be achieved within this context through the application of quality by design (QbD) principles and M&S, specifically by defining clinically relevant dissolution specifications (CRDS). To this end, it is essential to bridge in vitro results to drug product in vivo performance, emphasizing the need to explore the translational capacity of biopharmaceutics tools. Physiologically based M&S analyses offer a unique avenue for integrating the drug, drug product, and biological properties of a target organism to study their interactions on the pharmacokinetic response. Accordingly, Physiologically Based Biopharmaceutics Modeling (PBBM) has seen increasing use to support drug development and regulatory applications globally. In Brazil, a Model-Informed Drug Development (MIDD) policy and strategic project are not yet established, limiting applicability of M&S techniques. Drawing from the experience of the ANVISA-Academia PBBM Working Group (WG), this article assesses the opportunities and challenges for pharmacometrics (PMx) in Brazil and proposes strategies to advance the adoption of M&S analyses into regulatory decision-making.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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