What can Regulatory Bodies require ? 3. Package insert
Defining correctly the drug true potential
- PK/PD based “breakpoints” (which should be upper limits of MIC’s above which the prescriber needs to be warned that failures and selection of resistant strains are likely…)
- MIC-based posologies for serious infections (forget the notion of “mild” and “severe” infections”-based posologies)
- PK/PD-based recommendations for minimization of dose-related toxicities