Clinical Pharmacology Corner: FDA Public Meeting

The Food and Drug Administration (FDA) Will Host a Public Meeting on Mechanistic Absorption Modeling and Simulations in Oral Bioequivalent Product Development on May 19, 2016

The FDA will hold a public meeting on May 19, 2016, entitled “Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation.” The scope of the workshop covers the current status of mechanism-based absorption modeling and simulation from academia, industry, and regulatory perspectives. FDA seeks input from the public on when, where, and how to utilize mechanism-based absorption modeling and simulation in the context of development of bioequivalent oral drug products and regulatory evaluation of bioequivalence. The goals of this public meeting 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; and
• Obtain input from various stakeholders on when, where, and how mechanism-based absorption modeling and simulation should be applied in development of bioequivalent oral drug products and review of bioequivalence. 

Date:  Thursday, May 19, 2016, 8:30 a.m. - 4:30 p.m.

Location: FDA White Oak Campus, Building 31, the Great Room (Rm. 1503A)

Interested individuals can attend the meeting in person or via Web cast. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. Please register by April 19, 2016.

Learn more about the event at: http://www.fda.gov/Drugs/NewsEvents/ucm488178.htm (FR notice: https://www.federalregister.gov/articles/2016/03/07/2016-04965/mechanistic-oral-absorption-modeling-and-simulation-for-formulation-development-and-bioequivalence)

Register for the meeting by email to:
CDER-OGD-OfficeofResearchandStandardsAnnouncement@fda.hhs.gov

For further information contact: Xinyuan Zhang (email: Xinyuan.Zhang@fda.hhs.gov) or Liang Zhao (email: Liang.Zhao@fda.hhs.gov)