FDA Publishes Revised ICH M7(R1)

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FDA has published ICH’s revision of its mutagenic impurities guidance M7(R1). The revision adds a third appendix providing a list of abbreviations and a discussion of the application of the principles of the guidance to the calculation of compound-specific acceptable intakes (AIs). Included is a review of the considerations for the use of standard and alternative methods for AI calculations.

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