Strategies to Assess Drug-Drug Interactions when Developing Fixed Dose Combinations
Tuesday April 09, 2019
8:00 am
-
10:00 am
Eastern Time (ET)
Room W206 C
CVP
DDD
DMDD
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.
Speakers
Polina German
- Gilead Sciences, Inc.
Industry Perspectives: DDI Assessment for Fixed Dose Combinations
Nina Isoherranen
- University of Washington
Mechanisms of Drug–Drug Interactions Involving Multiple Inhibitors
Chao Liu
- The US FDA
Regulatory View on FDC Developments for Oncology and Anti-Infectives
George Drusano
- University of Florida
Identifying Optimal Combination Therapy for Mycobacterium Tuberculosis