Potential issues of learning and memory (LM) test methods in juvenile rat toxicity studies (JAS) for pediatric drug development

DOI
  • MINESHIMA Hiroshi
    Non-Clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association Drug Safety Research, Nonclinical Research Center, Otsuka Pharmaceutical Co., Ltd.
  • KATAGIRI Ryuichi
    Non-Clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association Translational Research Division, Chugai Pharmaceutical Co., Ltd.
  • KODAMA Terutaka
    Non-Clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association Toxicology and Pharmacokinetics Research Development, Research Institute, EA Pharma Co., Ltd.
  • KODAMA Toshihisa
    Non-Clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association Pre-Clinical Development, Clinical Platforms & Science, Japan Development, GlaxoSmithKline K.K.
  • KOTERA Takashi
    Non-Clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association Pharmacokinetics and Safety Assessment Dept., Discovery Research Labs., Nippon Shinyaku Co., Ltd.
  • SUZUKI Mutsumi
    Non-Clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association Translational Research Unit, R&D Division, Kyowa Kirin Co., Ltd.
  • SUGIMOTO Kazuko
    Non-Clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association Preclinical, Japan Regulatory Affairs, Medicines Developmental Unit Japan, Eli Lilly Japan K.K.
  • MATSUMOTO Kiyoshi
    Non-Clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association Drug Safety Research and Evaluation, Research, Takeda Pharmaceutical Company Limited
  • YAMAMOTO Toshinobu
    Non-Clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association Safety Research Laboratories, Sohyaku Innovation Research Division, Mitsubishi Tanabe Pharma Corporation
  • YAMAMOTO Masakatsu
    Non-Clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association Nonclinical Development, Regulatory Affairs, MSD K.K.

Bibliographic Information

Other Title
  • 幼若動物を用いた毒性試験における学習と記憶検査に関する課題

Abstract

<p>We surveyed the current situation of rat LM test methods using published papers and NDA dossiers. [Results and discussion] Several methods with various LM category and complexity of task were used in JAS. These methods in JAS were slightly different from academic research, and bridging between them seemed insufficient. In a survey of launched drugs, there still seemed to be methods with low detectability even if existing confounding factors which affect test results were considered. We concluded that further investigations were needed to establish recommended test methods.</p>

Journal

Details 詳細情報について

  • CRID
    1390004222614973184
  • NII Article ID
    130007898422
  • DOI
    10.14869/toxpt.47.1.0_p-232
  • Text Lang
    ja
  • Data Source
    • JaLC
    • CiNii Articles
  • Abstract License Flag
    Disallowed

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