1. Food and Drug Administration (FDA), Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Guidance for Industry: Q8 (R2) Pharmaceutical Development. 2009. [Internet]; Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073507.pdf
2. One-Factor-at-a-Time versus Designed Experiments
3. FDA, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. ICH, guidance for industry, Q9 quality risk management. 2006. [Internet]; Available from: http://www.fda.gov/downloads/Drugs/…/Guidances/ucm073511.pdf
4. FDA, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. ICH, guidance for industry, Q10 pharmaceutical quality system. 2009. [Internet]; Available from: http://www.fda.gov/downloads/Drugs/…/Guidances/ucm073517.pdf