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Ttc Intake  Form

Ttc Intake Form

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Video instructions and help with filling out and completing Ttc Intake Form

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Instructions and help about kaimosi ttc 2019 intake

- [Narrator] Welcome, it is my pleasure to present the poster title mutagenic impurities from a drug substance perspective, highlights from the ICH M7 Question and Answer draft document. The purpose of this poster is to highlight specific questions from the ICH M7 Q and A document regarding, when a total mutagenic impurity limit is applicable, when is it appropriate to use an Option 4 strategy? I will present two scenarios that address different aspects of this question. Is test data for potential mutagenic impurity that is consistently less than 30% TTC in multiple batches sufficient to justify no testing of that impurity in the control strategy. And finally, is periodic verification testing, i.e. skip testing, allowed for Option 2 and three control? Before proceeding, I would like to give a brief background on ICH M7. ICH M7 assessment and control of DNA reactive mutagenic impurities in pharmaceuticals to limit potential carcinogenic risk guidance reach step four in June of 2014. Thi

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