How to optimise drug study design

• Journal of Pharmacy and Pharmacology
• Differences and similarities in the design and conduct between dose-finding and efficacy studies
• Staggered dose escalation
• Intrapatient dose titration - 최적의 용량을 찾아냄.
  • 통계적인 분포.
  • NONMEM, MONOLIX etc
  • 상호관련
• Information needed for the planning of a dose-finding study and how this can be obtained
• Cystatin C - kidney function
• Bridging - 연결한다. 가정 - 성인에서의 PK와 비교. 소아에서는 dense sampling 못한다.
• AUC와 efficacy