Qualitative analysis of actual Standard for Exchange of Nonclinical Data (SEND) datasets for Data Domains: Proposition from Japan Pharmaceutical Manufacturers Association SEND Taskforce Team on standardization of nonclinical data

Gen Sato; Izumi Matsumoto; Mayumi Watanabe; Toshiko Kinomoto; Mikio Nakajima; Masakatsu Yamamoto; Yuki Inoue; Keita Kobayashi; Takashi Tanaharu; Akinori Kiya; Takafumi Yamaguchi; Hitomi Hayashi; Keiko Motoyama; Mutsumi Suzuki; Kazuto Watanabe

doi:10.1016/j.yrtph.2021.104919

Qualitative analysis of actual Standard for Exchange of Nonclinical Data (SEND) datasets for Data Domains: Proposition from Japan Pharmaceutical Manufacturers Association SEND Taskforce Team on standardization of nonclinical data

Regul Toxicol Pharmacol. 2021 Jun:122:104919. doi: 10.1016/j.yrtph.2021.104919. Epub 2021 Mar 20.

Authors

Affiliations

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; Eisai Co., Ltd., 5-1-3 Tokodai, Tsukuba-shi, Ibaraki, 300-2635, Japan. Electronic address: [email protected].
² 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 Dainippon Pharma Co., Ltd., 3-1-98 Kasugade-naka, Konohana-ku, Osaka, 554-0022, Japan.
³ 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.
⁴ Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; ZERIA Pharmaceutical Co., Ltd., 2512-1, Numagami, Oshikiri, Kumagaya-shi, Saitama, 360-0111, Japan.
⁵ 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.
⁶ 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.
⁷ 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.
⁸ Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; Kowa Company, Ltd., 332-1, OhnoShinden, Fuji-city, Shizuoka, 417-8650, Japan.
⁹ 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., Shinjuku i-Land Tower, 5-1, Nishi-Shinjuku 6-chome, Shinjuku-ku, Tokyo, 163-1327, Japan.
¹⁰ 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.
¹¹ Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; Eli Lilly Japan K.K., LILLY PLAZA ONE Bldg., 5-1-28, Isogamidori, Chuo-ku, Kobe, 651-0086, Japan.
¹² Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; Nippon Kayaku Co., Ltd., 31-12, Shimo 3-chome, Kita-ku, Tokyo, 115-0042, Japan.
¹³ 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.
¹⁴ 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.
¹⁵ Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA), 2-3-11, Nihombashi-honcho, Chuo-ku, Tokyo, 103-0023, Japan; Chugai Pharmaceutical Co., Ltd., 1-135 Komakado, Gotemba, Shizuoka, 412-8513, Japan.

PMID: 33753112
DOI: 10.1016/j.yrtph.2021.104919

Abstract

The Standard for Exchange of Nonclinical Data (SEND) has been adopted by the US FDA, which has required pharmaceutical companies who are developing new drugs for the US market to implement SEND. The Japan Pharmaceutical Manufacturers Association (JPMA) SEND Taskforce Team responded to this situation by starting a project to better understand the contents of SEND datasets. The project focused on domains generally included in the SEND domains for single- and repeat-dose general toxicology studies, and surveyed what kind of information are populated in which domains and in what way. The qualitative analysis of the results indicated that variations exist based on whether or not an individual variable was populated and on how the variable was populated. The Taskforce Team recommends reducing variations not only in the SEND datasets but also in the descriptions in the study protocol and/or final study report. Reduction of such variations should lead to higher quality datasets with powerful and increased searchability so that accumulated SEND datasets should become more valuable. These efforts would provide regulatory agencies with easier review of SEND datasets, which contributes to efficient development of new drug candidates.

Keywords: AMED; CDISC; JPMA; SEND.

MeSH terms

Biomedical Research / organization & administration
Biomedical Research / standards*
Databases as Topic / standards*
Drug Industry / standards*
Drugs, Investigational / standards
Humans
Japan
United States
United States Food and Drug Administration / standards

Substances

Drugs, Investigational