1. Quality-by-Design: Are We There Yet?
2. a ICH Q8 Pharmaceutical Development; U.S. Department of Health and Human Services, Food
and Drug Administration,
Center for Drug Evaluation and Research (CDER): Rockville, MD, August 2009.
3. b ICH 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. c ICH 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-Throughput Automation in Chemical Process Development