Document 1-1 Specialties/areas where placebo-controlled studies are difficult to conduct
Document 1-2 Specialties/areas where placebo-controlled studies are difficult to conduct(Modified version of the material of #1-1 for publishing purposes)
Document 2 Current situation and issues of placebo-controlled studies: antidepressants
Document 3 Necessity of phase III placebo-controlled studies as defined in the clinical evaluation guidelines
Document 4-1 Recent major phase III clinical study designs for antidiabetic drugs
Document 4-2 Recent major phase III clinical study designs for therapeutic drugs for osteoporosis
Document 5 Discussion on the placebo-controlled setting in PMDA's new drug review and consultation service