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Strategies to Assess Drug-Drug Interactions when Developing Fixed Dose Combinations

Tuesday April 09, 2019

8:00 am - 10:00 am

Room W206 C
Sponsored by the Division for Drug Metabolism and Disposition (DMDD)
Co-sponsored by the Division for Cardiovascular Pharmacology (CVP)
Co-sponsored by the Division for Drug Discovery and Development (DDD)
Co-sponsored by Division for Toxicology (TOX)

Chair :

Yurong Lai
Gilead Sciences Inc

Theoretically the drug interaction with a Fixed-Dose Congination can be antagonism, synergism, and potentiation. Therefore, assessing DDI potential for a FDC as a perpetrator practically can be challenge due to complicated mechanisms of interaction. The symposium will be offering the introduction of mechanisms of DDIs involving multiple inhibitors, the methods to assess the total inhibition effects, regulatory guidance on co-development of two or more new investigational drugs for use in combination, in vitro or preclinical data for human prediction and cases examples of DDI assessments to illustrate the strategy when developing FDCs.

Industry Perspectives: DDI Assessment for Fixed Dose Combinations
Polina German - Gilead Sciences, Inc.

Mechanisms of Drug–Drug Interactions Involving Multiple Inhibitors
Nina Isoherranen - University of Washington

Regulatory View on FDC Developments for Oncology and Anti-Infectives
Chao Liu - The US FDA

Identifying Optimal Combination Therapy for Mycobacterium Tuberculosis
George Drusano - University of Florida

Last Updated: August 15, 2019
Key Dates
April 6

ASPET Business Meeting and Awards Presentation

April 6-9

ASPET Annual Meeting at EB 2019

Thank you to our Annual Meeting partners:

University of Florida
Wake Forest University
Washington State University College of Pharmacy and Pharmaceutical Sciences
University of Wisconsin Molecular and Cellular Pharmacology Training Program
UT Health San Antonio
University of Minnesota

Emory University Pharmacology

PR & P
University of Michigan Medical School Pharmacology