title: [Development of a Guideline on Clinical investigation of Medicinal Product in the Treatment of Depression in Japan].
abstract: Drug development is one of the methods for qualitative improvement of medical treatment. The Ministry of Health, Labour and Welfare in Japan (MHLW) published "A Guideline on Clinical Investigation of Medicinal Product in the Treatment of Depression" in November 2010. The guideline was developed by a Japanese expert working group in psychiatry and regulatory science. The purpose of the guideline is to describe accepted principles and practices in the conduct of both individual clinical trials and development strategy for new medicinal products intended to be used for treating depression and to facilitate efficient drug development. This document describes the major issues discussed during the guideline development. This work was supported by Grants-in-Aid from the Research Committee of "A Guideline on Clinical Investigation of Medicinal Product in the Treatment of Depression", MHLW.
authors.affiliation: National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan. nakabayashi-dmc@umin.ac.jp
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Nakabayashi
mesh_terms: D000928:Antidepressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D003863:Depression / Q000188:drug therapy*; D004334:Drug Administration Schedule; D015195:Drug Design; D006801:Humans; D007564:Japan; D010919:Placebos; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic; D013997:Time Factors
chemical_list: D000928:Antidepressive Agents; D010919:Placebos