1. Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability;Chow,1995
2. ICH Q1A (R2): stability testing of new drug substances and products;International Conference on Harmonization;International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use,2003
3. ICH Q1E: evaluation for stability data;International Conference on Harmonization,2003
4. Economic Control of Quality of the Manufactured Product;Shewhart,1931
5. Introduction to Statistical Quality Control;Montgomery,2009