What can Regulatory Bodies require ? 2. Clinical data
Knowing what the drug can realistically make to the bugs in the patients
- PK parameters at both the individual and at the population level *
- Monte-Carlo simulations for efficacy based on population pharmacokinetics
- appropriate design of the phase II trials (human dose finding)
- justification of the dosage adopted for the pase III trials
- prospective definition of conditions that may lead to predictable failures
- minimization of toxicity