Human biological relevance and the use of threshold-arguments in regulatory genotoxicity assessment: experience with pharmaceuticals-Reference-Cited by-同舟云学术

Human biological relevance and the use of threshold-arguments in regulatory genotoxicity assessment: experience with pharmaceuticals

Published:2000-01 Issue:1 Volume:464 Page:19-34
ISSN:1383-5718
Container-title:Mutation Research/Genetic Toxicology and Environmental Mutagenesis
language:en
Short-container-title:Mutation Research/Genetic Toxicology and Environmental Mutagenesis

Author:

Müller Lutz,Kasper Peter

Publisher

Elsevier BV

Subject

Health, Toxicology and Mutagenesis,Genetics

Reference39 articles.

1. Interpretation of the biological relevance of genotoxicity test results: the importance of thresholds;Kirkland;Mutat. Res.,2000

2. The quality of genotoxicity testing of drugs. Experiences of a regulatory agency with new and old compounds;Müller;Mutagenesis,1991

3. EU, Testing of Medicinal Products for their Mutagenic Potential, The Rules Governing Medicinal Products in the European Union, vol. 3B, 1998 edn., pp. 45–50.

4. Y. Tazima, S. Kondo, Y. Kuroda, Problems of threshold in chemical mutagenesis, The Environmental Mutagen Society of Japan, Kokusai-bunken Printing, Tokyo, 1984.

5. ICH-harmonised guidances on genotoxicity testing of pharmaceuticals: evolution, reasoning and impact;Müller;Mutat. Res.,1999

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