1. ICH, Q1A(R2), ‘Stability Testing of New Drug Substances and Products’ 2003
2. ICH Q1D, ‘Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products’ 2002
3. Statistical Design and Analysis in Pharmaceutical Science
4. ICH Q1B, ‘Stability Testing: Photostability Testing of New Drug Substances and Products’ 1996
5. USP 35 General Chapter <1150>, ‘Pharmaceutical Stability’ 763 765