@article{oai:repo.qst.go.jp:00055699,
 author = {矢野, 恒夫 and 井上, 登美夫 and 伊藤, 健吾 and 千田, 道雄 and 佐治, 英郎 and 杉山, 雄一 and 渡辺, 恭良 and 栗原, 千絵子 and 米倉, 義晴 and 井上 登美夫 and 栗原 千絵子 and 米倉 義晴},
 issue = {2},
 journal = {臨床評価},
 month = {Feb},
 note = {This is a report proposing draft guidance for developing radiolabeled imaging drugs focusing on PET (positron emission tomography) and SPECT (single photon emission computed tomography) molecular imaging in Japan based on the guidance of developing medical imaging drugs by the U.S. FDA in June 2004. While "radiolabeled imaging drug  for disease diagnosis" in Japan should be established under the same standards as the New Drug Application (NDA) in the U.S. and Europe, it is urgent to formulate the development of our newly proposed "radiolabeled imaging drug for functional measurement" according to NDA standards from the new aspects of efficacy assessment of therapeutic drugs and early diagnosis.
 Our report is composed of a preface covering current regulatory comparisons among the U.S., Europe and Japan, followed by the draft guidance for developing radiolabeled imaging drugs, in which the following discussion points are clarified: (1) definition of a radiolabeled imaging drug, (2) clinical evaluation standards, (3) pharmacological, toxicological and radiological safety standards, (4) GMP, manufacturing and quality standards, and (5) questions and answers.
 Toxicological safety standard is discussed under the same standard as the M3(R2) guidance including Microdosing & E-IND studies at the ICH which was concluded by the final report on June 11, 2009 and then the U.S. FDA Guidance on January 20, 2010. 
  Both "radiolabeled imaging drug for functional measurement" and "radiolabeled imaging drug for patient management" are in a new category of functional diagnosis on biochemistry, biology and molecular biology. The former is able to detect and evaluate biomarker which is related to functional abnormality, and the latter is used for selection of patients or their therapeutic regimen based on functional diagnosis.
 The goal of this report is to offer an effective tool to facilitate the development of and creation of NDAs for radiolabeled imaging drugs and contribute to further discussions on the development of regulatory guidance by the MHLW (Ministry of Health, Labor and Welfare).},
 pages = {473--496},
 title = {放射性イメージング薬ガイダンスに関する草案},
 volume = {37},
 year = {2010}
}