1. Available guidance and best practices for conducting forced degradation studies;Reynolds;Pharm. Technol.,2002
2. Chapter 1: Stress Testing: Introduction;Baertschi,2005
3. FDA Guidance for industry INDs for phase 2 and phase 3 studies: chemistry, manufacturing and controls information. Federal Register 68, 27567–27568 (issued May 2003).
4. FDA, Submitting Documentation for the Stability of Human Drugs and Biologics, CDER,1987