Summary of Responses: Concentration-controlled and Dose-response
Community feedback:
- avoids suboptimal levels (conc. controlled)
- higher levels overcome resistant mutants
Industry concerns:
- real time reporting for dose adjustment is difficult
- high intra- and inter-subject variability
- patient adherence may impact results
- unclear which specific exposure measurement is best correlated with response (for investigational drugs)
- MTD (maximally tolerated dose) should be used in this population