1. International conference on harmonization, Pharmaceutical development Q8 (R2) (2009).
2. International conference on harmonization, Quality risk management Q9 (2008).
3. International conference on harmonization, Pharmaceutical quality system Q10 (2008).
4. International conference on harmonization, Development and manufacture of drug substances (chemical entities and biotechnological/biological entities) Q11 (2012).
5. Pharmaceutical quality by design: product and process development, understanding, and control;Yu;Pharm. Res.,2007