1. ICH 2009 Harmonised tripartite guideline: pharmaceutical development Q8 (R2) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Geneva
2. Sakuramill Sakuramil S2 mock of ICH Q11 Guideline regarding development and manufacture of drug substance http://www.nihs.go.jp/drug/section3/H23SakuramillMock(Eng).pdf