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The 2nd Meeting of the Subcommittee on Placebo-controlled Studies

Press Release

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Friday, January 9, 2015   15:00-17:00

Agenda / List of Handouts

  1. Current situation of placebo-controlled studies
  2. Others

List of Handouts

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

Minutes

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The 2nd Meeting of the Subcommittee on Placebo-controlled Studies
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