1. Guidance for Industry: INDs for Phase 2 and 3 Studies—Chemistry, Manufacturing, and Controls Information (Issued May 2003).
2. Guidance for Industry: Q1A(R2) Stability Testing of New Drug Substances and Products, CDER, (issued November 2003).
3. Pharmaceutical research and manufacturers association acceptable analytical practice No. 3: Forced degradation studies;Reynolds;Pharm Tech,2001
4. Solving tablet stability problems using forced degradation;Reynolds;Tablets and Capsules,2007
5. Pharmaceutical stress testing;Baertschi,2005