Food and Drug Administration
Center for Drug Evaluation and Research
Advisory Committee for
Pharmaceutical Science
Clinical Pharmacology
Subcommittee
Questions
2. Please comment on the case studies presented to the committee and the pros and cons of using clinical trial simulation (CTS) approaches to evaluate PK-PD (QT) study design. Are there other methods of analyzing PK-QT data that FDA should consider?
3. What critical design elements influence the outcome of a PK-QT study that has as its goal to identify a meaningful change in QT?
Topic
#3: Pediatric Bridging: Pediatric
Decision Tree
1. Please provide feedback on the pros and cons of the current pediatric decision tree and the changes that have been proposed in light of the examples that have been presented?
2. Please comment on the relevant adult data and information, as well as quantitative methods of analysis that determine the similarity between E-R in adults and pediatric patients.
3. How do we know that by adjusting dose and exposure we achieve efficacy and safety in all populations ? Under what circumstances do they predict deviations will occur ?
Food and Drug Administration
Center for Drug Evaluation and Research
Advisory Committee for
Pharmaceutical Science
Clinical Pharmacology
Subcommittee
Questions
Please
discuss the implications of drug interactions involving CYP2B6 and CYP2C8, and
what recommendations that FDA should provide to sponsors with regard to in vitro and in vivo drug-drug interaction studies?
Are the approaches presented to study the influence of pharmacogenetics on exposure-response sufficient and appropriate? Are there other criteria or approaches that FDA should consider recommending to sponsors?