Zdrowie i gospodarka · 7.03.2016
Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation; Public Workshop; Request for Comments
The Food and Drug Administration (FDA or the Agency) is announcing a public workshop entitled "Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation." The purposes of the workshop are to share current FDA experiences on the application of mechanism-based absorption modeling and simulation in regulatory activities; discuss current and future utility of mechanism-based absorption modeling and simulation in the development of bioequivalent oral drug products and regulatory reviews; obtain input from various stakeholders on when, where, and how to conduct mechanism-based absorption modeling and simulations in the context of bioequivalent product development; and request comments on these topics.