1. Reflection Paper on Methodological Issues in Confirmatory Clinical Trials Planned with an Adaptive Design,2007
2. Executive summary of the PhRMA Working Group on Adaptive Designs in Clinical Drug Development;Gallo;J. Biopharm. Stat.,2006
3. Good practices for adaptive clinical trials in pharmaceutical product development;Gaydos;Drug Inf. J.,2009
4. Ministry of Health, Labour and Welfare (MHLW). Basic principles on global clinical trials. Notification No.0928010, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, MHLW, September 28, 2007. Available at: http://www.pmda.go.jp/english/service/pdf/notifications/0928010-e.pdf.
5. PMDA, Review report of latanoprost and timolol maleate. November 10, 2009 (in Japanese). Available at: http://www.info.pmda.go.jp/shinyaku/g100102/40007900_22200AMX00232_A100_1.pdf.