Potentials and limitations of nonclinical safety assessment for predicting clinical adverse drug reactions: correlation analysis of 142 approved drugs in Japan-Reference-Cited by-同舟云学术

Potentials and limitations of nonclinical safety assessment for predicting clinical adverse drug reactions: correlation analysis of 142 approved drugs in Japan

Published:2013 Issue:4 Volume:38 Page:581-598
ISSN:0388-1350
Container-title:The Journal of Toxicological Sciences
language:en
Short-container-title:J. Toxicol. Sci.

Author:

Tamaki Chihiro¹²,Nagayama Takashi¹³,Hashiba Masamichi¹⁴,Fujiyoshi Masato¹,Hizue Masanori¹⁵,Kodaira Hiroshi¹⁶,Nishida Minoru¹⁷,Suzuki Kazuhiko¹⁸,Takashima Yoshiharu¹⁹,Ogino Yamato¹¹⁰,Yasugi Daisaku¹⁷,Yoneta Yasuo¹¹¹,Hisada Shigeru¹¹²,Ohkura Takako¹¹³,Nakamura Kazuichi¹¹⁴

Affiliation:

1. Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association

2. Preclinical, Japan Regulatory Affairs, Drug Development, Eli Lilly Japan K.K.

3. Non-Clinical Development, UCB Japan Co., Ltd.

4. Development Research, Mochida Pharmaceutical Co., Ltd.

5. DSRD-Tokyo, Pfizer Japan Inc.

6. Development Planning and Coordination, Pharmaceutical Research & Development, Yakult Honsha Co., Ltd.

7. Research & Development Center, Fuso Pharmaceutical Industries, Ltd.

8. Translational Sciences, Novartis Pharma K.K.

9. Preclinical Experts, Regulatory Affairs, Product Development Department, Bayer Yakuhin, Ltd.

10. Drug Research Department, Toa Eiyo Ltd.

11. Pharmacokinetics and Safety Research Department, Kaken Pharmaceutical Co., Ltd.

12. Developmental Research Center, ASKA Pharmaceutical Co., Ltd.

13. Department of Clinical Development, Maruishi Pharmaceutical Co., Ltd.

14. Global Regulatory Affairs Department, Shionogi & Co., Ltd.

Publisher

Japanese Society of Toxicology

Subject

Toxicology

Link

https://www.jstage.jst.go.jp/article/jts/38/4/38_581/_pdf

Reference32 articles.

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4. EMA (2010): EMEA/CHMP/SWP/150115/2006. Reflection paper of non-clinical evaluation of drug-induced liver injury (DILI).

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