Good Laboratory Practice (GLP) status of Asian countries and its implementation in non-clinical safety studies in pharmaceutical drug development

Author:

Sasaki Madoka1,Hinotsu Shiro1,Kawakami Koji1

Affiliation:

1. Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University

Publisher

Japanese Society of Toxicology

Subject

Toxicology

Reference35 articles.

1. Abe, Y. (2006): GLP situation in Asia. Obe-lisk, 11, 4-5.

2. Cyranoski, D. (2008): Pharmaceutical futures: made in China? Nature, 455, 1168-1170.

3. The price of innovation: new estimates of drug development costs

4. EPC (2004a): European Parliament and Council, Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP).

5. EPC (2004b): European Parliament and Council, Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonization of laws, regulations and administrative provision relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances.

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1. Principles of Good Laboratory Practice (GLP);Biomedical Product Development: Bench to Bedside;2020

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