Mutagenicity testing
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- The mutagenicity battery is satisfactorily filled; no further mutagenicity testing is recommended.
- Given the preponderance of negative assays using both in vitro and in vivo test systems we conclude that ZDBC is not mutagenic and that no additional mutagenicity testing is warranted.
- The usefulness of the tester strain TA102 in routine mutagenicity testing is discussed.
- An example from mutagenicity testing is discussed and data from it are used to illustrate the methodology.
- Since mutagenicity testing is not explicitly required for bio- logic therapeutics, as per the ICH 6 guidance document, the group considered testing inappropriate.
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