Multi-site study of an in vivo phototoxicity evaluation in Sprague-Dawley (SD) rats aimed at incorporating the phototoxicity assessments: effects of repeated administration and toxicokinetic blood collection on drug-induced phototoxicity

Author:

Yonezawa Yutaka1,Katou Hitoshi2,Kuga Kazuhiro3

Affiliation:

1. Pharmacokinetics and Safety Department Drug Research Center, Kaken Pharmaceutical Co., Ltd.

2. Kumamoto Laboratory, LSI Medience Corporation

3. Drug Safety Research and Evaluation, Takeda Pharmaceutical Company Limited

Publisher

Japanese Society of Toxicology

Reference17 articles.

1. Diffey, B.L., Daymond, T.J. and Fairgreaves, H. (1983): Phototoxic reactions to piroxicam, naproxen and tiaprofenic acid. Rheumatology, 22, 239-242.

2. Draize, J.H. (1959): Dermal toxicity. In: Appraisal of the safety of chemicals in foods, drugs and cosmetics. The Association of Food and Drug Officials of the United States, Texas State Department of Health, Austin, 46-59.

3. Food and Drug Administration. (2003). Guidance for Industry Photosafety Testing. Pharmacology Toxicology Coordinating Committee in the Centre for Drug Evaluation and Research (CDER) at the FDA.

4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2008). Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use S2 (R1).

5. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2009). Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals M3 (R2). In International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use.

Cited by 1 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. Overview of Safety Assessment and Toxicological Screening of Dermal Formulations;SBV Journal of Basic, Clinical and Applied Health Science;2020

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