Episode 5: Defending the Method: Regulatory Expectations and Where the Field Is Heading
How chiral methods and isolated standards are justified in a dossier, and a calibrated view of the future The regulatory position on stereochemical purity Regulators have treated stereochemistry as a quality and development issue for decades, and the core position has been stable even as the vocabulary evolved. FDA’s 1992 stereoisomer guidance requires that the …
Episode 5: Defending the Method: Regulatory Expectations and Where the Field Is Heading Read More »









