Exploratory Profiling of Enzyme Induction on Drug Disposition

PK parameter Treatment Point estimate of 90% treatment ratio Cl  

Exploratory Profiling of Enzyme Induction on Drug Disposition 

Concomitantly administered drugs have the potential to interact, i.e. their pharmacokinetics or pharmacodynamics can be altered (US FDA 1999 and references therein). Regulatory guidance suggests that if appropriately performed in-vitro studies indicate the lack of such an interaction, then a specific clinical study is not compulsory. Flowever, if the claim, No clinically relevant interaction with Drug X is desired in the product label, then a confirmatory clinical study is compulsory even if in-vitro studies indicated the lack of an interaction (EMEA CPMP/EWP/560/95 1997). 

Drug-drug interactions mediated by enzyme induction are less common than those mediated by enzyme inhibition. Drug-drug interactions due to enzyme induction are also less likely to cause safety issues, except toxic if a toxic metabolite is formed by metabolite activation, however, they may affect 

The design of a study providing the suggested exploratory profiling of the effect of Drug XYZ on 

---

II.S.8 Exploratory Profiling of Enzyme Induction on Drug Disposition 683... 

---