Potential issues associated with the introduction of virtual control groups into non-clinical toxicology studies

DOI Web Site 参考文献15件
  • SATO Gen
    Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan Eisai Co., Ltd., 5-1-3 Tokodai, Tsukuba-shi, Ibaraki 300-2635, Japan
  • NAKAJIMA Mikio
    Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan Asahi Kasei Pharma Corporation, 632-1 Mifuku Izunokuni-shi, Shizuoka 410-2321, Japan
  • SAKAI Kuniyoshi
    Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan ASKA Pharmaceutical Co., Ltd., Shonan Health Innovation Park #B31F-1110, 2-26-1 Muraoka-higashi, Fujisawa, Kanagawa 251-8555, Japan
  • TOGASHI Yuko
    Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan EA Pharma Co., Ltd., 1-1 Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa 210-8681, Japan
  • YAMAMOTO Masakatsu
    Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan MSD K.K., Urban Ace Kitahama Bldg., 2-3-7 Hiranomachi, Chuo-ku, Osaka-city, Osaka 541-0046, Japan
  • INOUE Yuki
    Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan Otsuka Pharmaceutical Co., Ltd., 463-10 Kagasuno, Kawauchi-cho, Tokushima 771-0192, Japan
  • OSHIMA Takeshi
    Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan Kyowa Kirin Co., Ltd., 1188, Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8731, Japan
  • SOH Tetsuyoshi
    Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan Shionogi & Co., Ltd., 3-1-1, Futaba-Cho, Toyonaka, Osaka 561-0825, Japan
  • WATANABE Mayumi
    Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan Daiichi Sankyo Co., Ltd., 1-16-13, Kitakasai, Edogawa-ku, Tokyo 134-8630, Japan
  • MATSUMOTO Izumi
    Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan Sumitomo Pharma Co., Ltd., 3-1-98 Kasugade-naka, Konohana-ku, Osaka 554-0022, Japan
  • YAMAMOTO Toshinobu
    Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan Mitsubishi Tanabe Pharma Corporation, Shonan Health Innovation Park, 2-26-1 Muraoka-Higashi, Fujisawa, Kanagawa 251-8555, Japan
  • TANAHARU Takashi
    Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan Bristol-Myers Squibb K.K., Otemachi One tower 1-2-1 Otemachi, Chiyoda-ku, Tokyo 100-0004, Japan
  • KAWAKAMI Akio
    Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan Merck Biopharma Co., Ltd., Arco Tower 4F, 1-8-1 Shimomeguro, Meguro-ku, Tokyo 153-8926, Japan
  • MOTOYAMA Keiko
    Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan Janssen Pharmaceutical K.K., 3-5-2 Nishi-kanda, Chiyoda-ku, Tokyo 101-0065, Japan
  • HASHIMOTO Kiyohiro
    Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan Takeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa 251-8555, Japan
  • SUZUKI Mutsumi
    Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan Kyowa Kirin Co., Ltd., 1188, Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8731, Japan

抄録

<p>In recent years, introducing virtual control groups (VCGs) into toxicology studies is increasingly discussed because of the 3Rs and non-human primate (NHP) supply issues. Evaluating toxicology study results using historical control data is not new; however, introducing a VCG means replacing the concurrent control group in a toxicology study with a VCG, thereby reducing the number of animals used by approximately 30%. While it may be possible to conduct a toxicology study of a developmental compound in which the concurrent control group is replaced with a VCG, the scientific appropriateness of introducing a VCG and its regulatory acceptability needs to be considered. Therefore, we identified the following five issues that may arise when implementing a VCG: 1) regulatory requirements, 2) common issues when introducing a VCG, 3) issues related to histopathological examinations when introducing a VCG, 4) statistical analysis when introducing a VCG, and 5) facility monitor (sentinel) animals. Current regulatory guidelines require a concurrent control group for a pivotal toxicology study, whose results, if do not meet the requirements of these guidelines, cannot be used for new drug approval applications. Even if the use of VCGs is justified from animal welfare and scientific points of view, it is critical that the industry work with health authorities to ensure that data from these studies are accepted. The Japan Pharmaceutical Manufacturers Association will continue to hold necessary discussions with key stakeholders to accelerate efficient and effective new drug development pertaining to the use of VCGs.</p>

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