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

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 w...

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Bibliographic Details
Published in:The AAPS journal 2024-01, Vol.26 (1), p.12-12, Article 12
Main Authors: Walenga, Ross L., Babiskin, Andrew H., Bhoopathy, Sid, Clarke, James F., De Backer, Jan, Ducharme, Murray, Kelly, Marc, Le Merdy, Maxime, Yoon, Miyoung, Roy, Partha
Format: Article
Language:English
Subjects:
Best Practices for Utilizing Modeling Approaches to Support Generic Product Development: A Series of Workshop Summary Reports
Biochemistry
Biomedical and Life Sciences
Biomedicine
Biotechnology
Computer Simulation
Desoximetasone
Drug approval
Drugs, Generic
Generic drugs
Meeting Report
Pharmaceutical Preparations
Pharmacology/Toxicology
Pharmacy
Therapeutic Equivalency
United States
United States Food and Drug Administration
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Summary: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. Graphical Abstract
ISSN:1550-7416
1550-7416
DOI:10.1208/s12248-023-00879-2