1. aA glossary section with definitions of terms used within this text is included inAppendix 1.
2. bICH Q8 Pharmaceutical Development,(R2);U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER):Rockville, MD, Aug 2009.
3. cICH Q9 Quality Risk Management;U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER):Rockville, MD, June 2006.
4. dICH Q10 Pharmaceutical Quality System;U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER):Rockville, MD, April 2009.
5. High fidelity mathematical model building with experimental data: A Bayesian approach