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David Snodin. For decades, regulators have grappled with different approaches to address the issue of control of impurities. Safety-based limits, such as permissible daily exposure (PDE ...
About. Specialties: Recent publication: Genotoxic impurities: a regulatory toxicology commentary on recent articles in Organic Process Research and Development:...
May 21, 2013 · Dr. David Snodin studied Chemistry at Imperial College, London, moving to Bristol University to undertake research for a Ph.D. in Organic Chemistry. He later obtained an M.Sc. in Toxicology at the University of Surrey.
May 26, 2015 · david snodin. Principal at Xiphora Biopharma Consulting. Published May 26, 2015. + Follow. Mutagenic Alkyl-Sulfonate Impurities in Sulfonic Acid Salts: Reviewing the Evidence and Challenging...
The cancer TTC (Threshold of Toxicological Concern) concept is currently employed as an aid to risk assessment of potentially mutagenic impurities (PMIs) in food, cosmetics and other sectors.
David Snodin, Principal, Xiphora Biopharma Consulting, UK. Keywords ICH M7 guideline; Mutagenic impurity; Active pharmaceutical ingredient (API); Scope; Nomenclature; M7 principles;
ICH/regional guidances and agency scrutiny provide the regulatory framework for safety assessment and control of impurities in small-molecule drug substances and drug products.
