On May 19, 2016, FDA will hold a public workshop titled “Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation”. Modeling and simulation tools help with developing bioequivalence and regulatory evaluation for oral drug products.
In this workshop, the FDA will share its current thinking on mechanism-based absorption modeling and simulation in regulatory activities and obtain public input on future applications in bioequivalence determination and other regulatory activities for oral drug products.
Modeling and simulation tools are among the research priorities of the Regulatory Science program created by the Generic Drug User Fee Amendments of 2012 (GDUFA). The advancement of modeling and simulation tools impacts the other GDUFA Regulatory Science research priorities and is essential to modernizing the ANDA review process.
Individuals who wish to attend this workshop, in person or via webcast, should email CDER-OGD-OfficeofResearchandStandardsAnnouncement@fda.hhs.gov by April 19, 2016 to register.
Submit comments on this workshop through the public workshop docket. The deadline for submitting either electronic or written comments is June 20, 2016.
May 19, 2016
8:30 AM – 4:30 PM
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center, the Great Room (Rm. 1503B&C)
Silver Spring, MD 20993-0002
- Modeling and Simulations for Development and Bioequivalence Evaluation of a Generic Drug Product
- Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence (BE) Evaluation
- Mechanistic Modeling and Simulation of Oral Drug Absorption: Opportunities and Challenges
- Incorporating Mechanistic Modeling & Simluation to Assist with Formulation Development and Regulatory Evaluations
- PK-Sim for Mechanistic Oral Absorption Modeling and Simulation and More
- FDA Public Workshop on Oral Absorption Modeling and Simulation
- Workshop: Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation
- Application of Mechanistic Oral Absorption Model in Biopharmaceutics Review
- Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: An Industry Perspective