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Table 3 Risk characterization for acceptable intake levels

From: Analytical approaches to ensure product quality -- AAPS Joint Face-to-Face Meeting of the Stability, the Pharmaceutical Impurities, and the CMC Statistics Focus Groups, April 6th, 2016 in Gaithersburg, MD

• TTC-based acceptable intakes

• Develop compound-specific limits when carcinogenicity data available

• Acceptable intakes based on compound-specific risk assessments

• Acceptable intakes based on Less than lifetime (staged TTC) limit concept

• Acceptable total daily intakes for multiple impurities

• Exceptions and flexibility in approaches

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