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International Journal of Pharmaceutical Medicine, Vol. 18, Iss. 4, 2004-01 ,pp. : 215-220

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Setting Limits for Genotoxic Impurities in Drug Substances: Threshold-Based and Pragmatic Approaches

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Acceptability of Low Levels of Genotoxic Impurities in New Drug Substances: Conclusions of the Drug Information Association (DIA)/European Medicines Agency (EMEA) Workshop, October 27-28, 2003 in London, UK

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Validating New Toxicology Tests for Regulatory Acceptance

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International symposium on genotoxic and carcinogenic thresholds

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