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Discussion paper: Phantom alkyl-sulfonate impurities in sulfonate-salt drug substances. Challenging the basis of a recent article by Yao and Shan et al., 2024 concerning the solid-phase extraction of alkyl-tosylate impurities

Journal of Chromatography A, 2024-09, Vol.1733, p.465213, Article 465213

Snodin, David J

2024

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Mutagenic impurities in pharmaceuticals: A critical assessment of the cohort of concern with a focus on N-nitrosamines

Regulatory toxicology and pharmacology, 2023-06, Vol.141, p.105403-105403, Article 105403

Snodin, David J.

2023

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A Primer for Pharmaceutical Process Development Chemists and Analysts in Relation to Impurities Perceived to Be Mutagenic or “Genotoxic”

Organic process research & development, 2020-11, Vol.24 (11), p.2407-2427

Snodin, David J

2020

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Elusive ImpuritiesEvidence versus Hypothesis. Technical and Regulatory Update on Alkyl Sulfonates in Sulfonic Acid Salts

Organic process research & development, 2019-05, Vol.23 (5), p.695-710

Snodin, David J

2019

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Short commentary on NDMA (N-nitrosodimethylamine) contamination of valsartan products

Regulatory toxicology and pharmacology, 2019-04, Vol.103, p.325-329

2019

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Genotoxic Impurities: From Structural Alerts to Qualification

Organic process research & development, 2010-07, Vol.14 (4), p.960-976

Snodin, David J

2010

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Tolerability of risk: A commentary on the nitrosamine contamination issue

Journal of pharmaceutical sciences, 2021-06, Vol.110 (6), p.2311-2328

2021

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Mechanisms of Nitrosamine Mutagenicity and Their Relationship to Rodent Carcinogenic Potency

Chemical research in toxicology, 2024-02, Vol.37 (2), p.181-198

2024

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Genotoxic Impurities: A Regulatory Toxicology Commentary on Recent Articles in Organic Process Research & Development

Organic process research & development, 2011-11, Vol.15 (6), p.1243-1246

Snodin, David J

2011

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Unnecessary Development of Highly Sensitive Assays for Potentially Mutagenic Impurities (PMIs)

Organic process research & development, 2014-03, Vol.18 (3), p.360-361

Snodin, David J

2014

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Guidelines and pharmacopoeial standards for pharmaceutical impurities: Overview and critical assessment

Regulatory toxicology and pharmacology, 2012-07, Vol.63 (2), p.298-312

2012

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Mutagenic impurities in pharmaceuticals: A critique of the derivation of the cancer TTC (Threshold of Toxicological Concern) and recommendations for structural-class-based limits

Regulatory toxicology and pharmacology, 2013-11, Vol.67 (2), p.299-316

2013

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Drug substances presented as sulfonic acid salts: overview of utility, safety and regulation

Journal of pharmacy and pharmacology, 2009-03, Vol.61 (3), p.269-278

2009

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Residues of genotoxic alkyl mesylates in mesylate salt drug substances: Real or imaginary problems?

Regulatory toxicology and pharmacology, 2006-06, Vol.45 (1), p.79-90

Snodin, David J.

2006

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Potentially Mutagenic Impurities (PMIs): Optimizing Toxicological and Analytical Assessments

Organic process research & development, 2014-07, Vol.18 (7), p.836-839

Snodin, David

2014

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Mutagenic Alkyl-Sulfonate Impurities in Sulfonic Acid Salts: Reviewing the Evidence and Challenging Regulatory Perceptions

Organic process research & development, 2015-11, Vol.19 (11), p.1465-1485

2015

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Regulatory immunotoxicology: does the published evidence support mandatory nonclinical immune function screening in drug development?

Regulatory toxicology and pharmacology, 2004-12, Vol.40 (3), p.336-355

Snodin, David J.

2004

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An EU perspective on the use of in vitro methods in regulatory pharmaceutical toxicology

Toxicology Letters, 2002-02, Vol.127 (1), p.161-168

Snodin, David J.

2002

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Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals

BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy, 2006, Vol.20 (1), p.25-52

2006

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Genotoxic Impurities in Drug Substances

Organic process research & development, 2009-05, Vol.13 (3), p.409-409

Snodin, David

2009

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Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)

Regulatory toxicology and pharmacology, 2023-08, Vol.142, p.105415-105415, Article 105415

2023

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Implementation of ICH S6: EU Perspective

Preclinical Safety Evaluation of Biopharmaceuticals, 2008, p.67-92

2008

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Alternatives models in carcinogenicity testing: A European perspective : Genetically altered models as replacements for the conventional mouse bioassay: Challenges for pathologists in drug development

Toxicologic pathology, 2002, Vol.30 (1), p.157-159

2002

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Alternatives Models in Carcinogenicity Testing—A European Perspective

Toxicologic pathology, 2002-01, Vol.30 (1), p.157-159

2002

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Discussion paper: Phantom alkyl-sulfonate impurities in sulfonate-salt drug substances. Challenging the basis of a recent article by Yao and Shan et al., 2024 concerning the solid-phase extraction of alkyl-tosylate impurities

Mutagenic impurities in pharmaceuticals: A critical assessment of the cohort of concern with a focus on N-nitrosamines

A Primer for Pharmaceutical Process Development Chemists and Analysts in Relation to Impurities Perceived to Be Mutagenic or “Genotoxic”

Elusive ImpuritiesEvidence versus Hypothesis. Technical and Regulatory Update on Alkyl Sulfonates in Sulfonic Acid Salts

Short commentary on NDMA (N-nitrosodimethylamine) contamination of valsartan products

Genotoxic Impurities: From Structural Alerts to Qualification

Tolerability of risk: A commentary on the nitrosamine contamination issue

Mechanisms of Nitrosamine Mutagenicity and Their Relationship to Rodent Carcinogenic Potency

Genotoxic Impurities: A Regulatory Toxicology Commentary on Recent Articles in Organic Process Research & Development

Unnecessary Development of Highly Sensitive Assays for Potentially Mutagenic Impurities (PMIs)

Guidelines and pharmacopoeial standards for pharmaceutical impurities: Overview and critical assessment

Mutagenic impurities in pharmaceuticals: A critique of the derivation of the cancer TTC (Threshold of Toxicological Concern) and recommendations for structural-class-based limits

Drug substances presented as sulfonic acid salts: overview of utility, safety and regulation

Residues of genotoxic alkyl mesylates in mesylate salt drug substances: Real or imaginary problems?

Potentially Mutagenic Impurities (PMIs): Optimizing Toxicological and Analytical Assessments

Mutagenic Alkyl-Sulfonate Impurities in Sulfonic Acid Salts: Reviewing the Evidence and Challenging Regulatory Perceptions

Regulatory immunotoxicology: does the published evidence support mandatory nonclinical immune function screening in drug development?

An EU perspective on the use of in vitro methods in regulatory pharmaceutical toxicology

Understanding and applying regulatory guidance on the nonclinical development of biotechnology-derived pharmaceuticals

Genotoxic Impurities in Drug Substances

Acceptable intakes (AIs) for 11 small molecule N-nitrosamines (NAs)

Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: is aromatic N-oxide a structural alert for predicting DNA-reactive mutagenicity?

Implementation of ICH S6: EU Perspective

Alternatives models in carcinogenicity testing: A European perspective : Genetically altered models as replacements for the conventional mouse bioassay: Challenges for pathologists in drug development

Alternatives Models in Carcinogenicity Testing—A European Perspective

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