Mutagenic Impurities from a Drug Substance Perspective: Highlights from ICH M7 Q&A Draft Document

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  • Опубликовано: 12 сен 2024
  • Submit proposed questions on this poster to DMFWorkshop2021@fda.hhs.gov by March 19, 2021, and tune in for the subsequent panel discussion during the Drug Master File (DMF) and Drug Substance follow-up webinar on April 9, 2021.
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    This poster discusses four topics covered in the new ICH M7 Question and Answer Draft Document surrounding the control of mutagenic impurities.
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