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.

1. Abboud, G. and Kaplowitz, N. (2007): Drug-induced liver injury. Drug Saf., 30, 277-294.

2. Betton, G., Cockburn, A., Harpur, E., Hopkins, J., Illing, P., Lumley, C. and Connors, T. (1994): A critical review of the optimum duration of chronic rodent testing for the determination of non-tumourigenic toxic potential: a report by the BTS Working Party on Duration of Toxicity Testing. Hum. Exp. Toxicol., 13, 221-232.

3. Department of Health (2006): Expert Group on Phase One Clinical Trials: Final report. http://webarchive.nationalarchives.gov.uk/20130107105354/, http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_063117

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

5. FDA (2005): Guidance for industry: Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers.

Cited by 65 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Complex in vitro models positioned for impact to drug testing in pharma: a review;Biofabrication;2024-08-27

2. Translation of nonclinical to clinical safety findings for 27 biotherapeutics;Toxicology and Applied Pharmacology;2024-03

3. Mera: A scalable high throughput automated micro-physiological system;SLAS Discovery;2023-12

4. Mera: A scalable high throughput automated micro-physiological system;SLAS Technology;2023-08

5. Accurate clinical toxicity prediction using multi-task deep neural nets and contrastive molecular explanations;Scientific Reports;2023-03-25