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Proc Natl Acad Sci U.S.A

To view or add a comment, sign in I appreciated the opportunity to be interviewed by Nick Paul Taylor for this BioSpace article discussing the FDAs recently published draft guidance, General Considerations for the Use of New Approach Methodologies in Drug Development. Historically, drug developers have often included in vitro NAM assay reports in regulatory submissions with limited explanatory context, resulting in minimal impact on the regulators safety assessment

It is essential to select non-toxic cryoprotectants to ensure oocyte preservation, facilitate fertilization, and support subsequent embryo development []