Genotoxicity Testing of API

Fortunately the frequency of mutagenic drug candidates recognized in early drug development is very low because positive Ames bacterial mutagenicity test results usually have severe ramifications with APIs dropped from further development. While negative results in the appropriate follow-up tests (e.g., mouse carcinogenicity studies) could enable progression of API development, pragmatically the cost and long duration required for these tests means that most pharmaceutical companies drop mutagenic APIs from development and quickly move on to another drug candidate.

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