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

Author:

SATO Gen12,NAKAJIMA Mikio13,SAKAI Kuniyoshi14,TOGASHI Yuko15,YAMAMOTO Masakatsu16,INOUE Yuki17,OSHIMA Takeshi18,SOH Tetsuyoshi19,WATANABE Mayumi110,MATSUMOTO Izumi111,YAMAMOTO Toshinobu112,TANAHARU Takashi113,KAWAKAMI Akio114,MOTOYAMA Keiko115,HASHIMOTO Kiyohiro116,SUZUKI Mutsumi18

Affiliation:

1. Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11 Nihombashi-honcho, Chuo-ku, Tokyo 103-0023, Japan

2. Eisai Co., Ltd., 5-1-3 Tokodai, Tsukuba-shi, Ibaraki 300-2635, Japan

3. Asahi Kasei Pharma Corporation, 632-1 Mifuku Izunokuni-shi, Shizuoka 410-2321, Japan

4. ASKA Pharmaceutical Co., Ltd., Shonan Health Innovation Park #B31F-1110, 2-26-1 Muraoka-higashi, Fujisawa, Kanagawa 251-8555, Japan

5. EA Pharma Co., Ltd., 1-1 Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa 210-8681, Japan

6. MSD K.K., Urban Ace Kitahama Bldg., 2-3-7 Hiranomachi, Chuo-ku, Osaka-city, Osaka 541-0046, Japan

7. Otsuka Pharmaceutical Co., Ltd., 463-10 Kagasuno, Kawauchi-cho, Tokushima 771-0192, Japan

8. Kyowa Kirin Co., Ltd., 1188, Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8731, Japan

9. Shionogi & Co., Ltd., 3-1-1, Futaba-Cho, Toyonaka, Osaka 561-0825, Japan

10. Daiichi Sankyo Co., Ltd., 1-16-13, Kitakasai, Edogawa-ku, Tokyo 134-8630, Japan

11. Sumitomo Pharma Co., Ltd., 3-1-98 Kasugade-naka, Konohana-ku, Osaka 554-0022, Japan

12. Mitsubishi Tanabe Pharma Corporation, Shonan Health Innovation Park, 2-26-1 Muraoka-Higashi, Fujisawa, Kanagawa 251-8555, Japan

13. Bristol-Myers Squibb K.K., Otemachi One tower 1-2-1 Otemachi, Chiyoda-ku, Tokyo 100-0004, Japan

14. Merck Biopharma Co., Ltd., Arco Tower 4F, 1-8-1 Shimomeguro, Meguro-ku, Tokyo 153-8926, Japan

15. Janssen Pharmaceutical K.K., 3-5-2 Nishi-kanda, Chiyoda-ku, Tokyo 101-0065, Japan

16. Takeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa 251-8555, Japan

Publisher

AMED iD3 Catalyst Unit

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