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2.4.7 Section 7 – Risk Characterization

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This section has five Q&As that start with a direct continuation to Q&A 6.4, which relates to Ames positive impurities. Then an interesting question is presented regarding the application of the LTL to AIs derived by linear extrapolation from TD50 values but not to PDEs derived for impurities. Then a Q&A relates to the explanations and implications of moving HIV disease from treatment duration of <10 years to lifetime treatment, and finally a Q&A relates to the application of limits for individual impurities when three or more Class 2 and Class 3 impurities are present.

Mutagenic Impurities

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