1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH Harmonised Guideline Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Q12;ICH Guidelines,2017
2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Pharmaceutical Development Q8(R2);ICH Guidelines,2009
3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Quality Risk Management Q9;ICH Guidelines,2005
4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Development and Manufacture of Drug Substances Q11;ICH Guidelines,2012
5. Bioprocess optimization using design-of-experiments methodology;Mandenius;Biotechnol Prog,2008