Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products.

Autor: Walenga RL; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. Ross.Walenga@fda.hhs.gov., Babiskin AH; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Bhoopathy S; Pharmaron US Lab Services and CGT, Exton, Pennsylvania, USA., Clarke JF; Simcyp Division, Certara UK, Sheffield, UK., De Backer J; FLUIDDA INC., New York, NY, USA., Ducharme M; Learn and Confirm Inc., St-Laurent, Québec, Canada.; University of Montréal, Montréal, Québec, Canada., Kelly M; Global Inhalation R&D, Teva, London, UK., Le Merdy M; Simulations Plus, Inc., Lancaster, California, USA., Yoon M; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Roy P; Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Jazyk: angličtina
Zdroj: The AAPS journal [AAPS J] 2024 Jan 04; Vol. 26 (1), pp. 12. Date of Electronic Publication: 2024 Jan 04.
DOI: 10.1208/s12248-023-00879-2
Abstrakt: Evidence shows that there is an increasing use of modeling and simulation to support product development and approval for complex generic drug products in the USA, which includes the use of mechanistic modeling and model-integrated evidence (MIE). The potential for model reuse was the subject of a workshop session summarized in this review, where the session included presentations and a panel discussion from members of the U.S. Food and Drug Administration (FDA), academia, and the generic drug product industry. Concepts such as platform performance assessment and MIE standardization were introduced to provide potential frameworks for model reuse related to mechanistic models and MIE, respectively. The capability of models to capture formulation and product differences was explored, and challenges with model validation were addressed for drug product classes including topical, orally inhaled, ophthalmic, and long-acting injectable drug products. An emphasis was placed on the need for communication between FDA and the generic drug industry to continue to foster maturation of modeling and simulation that may support complex generic drug product development and approval, via meetings and published guidance from FDA. The workshop session provided a snapshot of the current state of modeling and simulation for complex generic drug products and offered opportunities to explore the use of such models across multiple drug products.
(© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)
Databáze: MEDLINE
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