… view of participating PhRMA member companies for the conduct of in vitro and in vivo
drug-drug interaction studies … , ST) metabolic and transporter interactions. This article outlines a …

… and the FDA Center for Drug Evaluation and Research (CDER), PhRMA was invited by the
… on the conduct of drug-drug interaction studies. Consequently, a PhRMA subcommittee was …

… The first approach is to use the fold-change method in which … The second approach is to use
the relative induction score (RIS… approach is to calculate a predicted ratio of the victim drug’s …

… of Drug Interaction Studies,'… drug interaction studies in recent new drug development. This
review summarizes current situations and further discussion points on drug interaction studies …

… studies.l" While many FDA guidances refer to the bioequivalence guidance (food effect,
controlled release, and drug interaction, … Last, general recommendations on an overall approach …

… strategy in predicting the victim drug-drug interaction (DDI) liability due to modulation of
drug metabolizing enzymes. Presented in this perspective are the recommendations from this …

… the industry to predict drug-drug interactions due to P450 induction. The key objectives of
this effort were as follows: 1) identify the current practices used by PhRMA member companies; …

… provides regulatory perspectives on metabolism- and transport-based drug interactions. …
A tiered approach proposed by the PhRMA Drug Metabolism Technical Group appeared useful …

… The next steps include extending the above described approach to drug transporters and …
need to perform additional clinical trials (eg, drug-drug interaction studies) or to use tailored …

… drug−drug interactions in vivo. This commentary will focus on the role that drug transporters
may play in drug−drug interactions … drug development to address potential drug interactions …