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In clinical studies, many patients with ASD have increased levels of propionic acid in the stool, as well as a history of previous infections
10.1371/journal.pone.0106890 5 Al-ZamelN.Al-SabahS.LuqmaniY.AdiL.ChackoS.SchneiderT
doi: 10.1016/j.mrfmmm.2010.05.003 152
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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the opportunity to be interviewed by Nick Paul Taylor for this BioSpace article discussing the FDAs recently published draft guidance, General Considerations for the Use of New Approach Methodologies in Drug Development.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
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