1. U.S. Department of Health and Human Services - Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry—dissolution testing of immediate release solid oral dosage forms. 1997.
2. Woodcock J. The concept of pharmaceutical quality. American Pharmaceutical Review. 2004;7(6).
3. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH). ICH Harmonized Tripartite Guideline: Pharmaceutical Development, ICH Q8 (R2); 2009.
4. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH). ICH Harmonized Tripartite Guideline: Quality Risk Management, ICH Q9; 2005.
5. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH). ICH Harmonized Tripartite Guideline: Pharmaceutical Quality System, ICH Q10; 2005.