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1

Genotoxic Impurities: From Structural Alerts to Qualification

Snodin, David J.

Journal:

Organic Process Research & Development

Year:

2010

Language:

english

File:

PDF, 578 KB

english, 2010

2

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

Snodin, David J.

Journal:

Organic Process Research & Development

Year:

2020

File:

PDF, 2.10 MB

2020

3

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

Snodin, David J., McCrossen, Sean D.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2013

Language:

english

File:

PDF, 1007 KB

english, 2013

4

Understanding and Applying Regulatory Guidance on the Nonclinical Development of Biotechnology-Derived Pharmaceuticals

Dr David J. Snodin,Peter R. Ryle

Journal:

Year:

2006

Language:

english

File:

PDF, 360 KB

english, 2006

5

Setting Limits for Genotoxic Impurities in Drug Substances

David Kirkland,David Snodin

Journal:

Pharmaceutical Medicine

Year:

2004

Language:

english

File:

PDF, 163 KB

english, 2004

6

Notes

AD STIJNMAN, RALPH HYDE, ALBERTO MILANO, CRAIG HARTLEY, STEPHEN COPPEL, MICHAEL SNODIN, DAVID LANDAU and ANTONY GRIFFITHS

Journal:

Print Quarterly

Year:

1991

Language:

english

File:

PDF, 2.50 MB

english, 1991

7

Food toxicology: Real or imaginary problems?: Edited by G. G. Gibson and R. Walker. Taylor and Francis, London, 1985. 403 pp. Price: £40.00

Journal:

Year:

1986

Language:

english

File:

PDF, 96 KB

english, 1986

8

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

David P. Elder, David J. Snodin

Journal:

Journal of Pharmacy and Pharmacology

Year:

2009

Language:

english

File:

PDF, 269 KB

english, 2009

9

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

Snodin, David J

Journal:

Organic Process Research & Development

Year:

2011

Language:

english

File:

PDF, 700 KB

english, 2011

10

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

David J. Snodin

Journal:

Regulatory Toxicology and Pharmacology

Year:

2006

Language:

english

File:

PDF, 209 KB

english, 2006

11

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

David J. Snodin, Sean D. McCrossen

Journal:

Regulatory Toxicology and Pharmacology

Year:

2012

Language:

english

File:

PDF, 527 KB

english, 2012

12

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

David J. Snodin

Journal:

Regulatory Toxicology and Pharmacology

Year:

2004

Language:

english

File:

PDF, 428 KB

english, 2004

13

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

David J. Snodin

Journal:

Toxicology Letters

Year:

2002

Language:

english

File:

PDF, 91 KB

english, 2002

14

Genotoxic Impurities in Drug Substances

Journal:

Organic Process Research & Development

Year:

2009

Language:

english

File:

PDF, 44 KB

english, 2009

15

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

Snodin, David J.

Journal:

Organic Process Research & Development

Year:

2014

Language:

english

File:

PDF, 315 KB

english, 2014

16

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

Journal:

Organic Process Research & Development

Year:

2014

Language:

english

File:

PDF, 681 KB

english, 2014

17

The reactions of aryloxysulphoxonium salts with amines and other nucleophiles

Chalkley, G. Roger, Snodin, David J., Stevens, Graham, Whiting, Mark C.

Journal:

Journal of the Chemical Society Perkin Transactions 1

Year:

1978

Language:

english

File:

PDF, 1.06 MB

english, 1978

18

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

Snodin, David, Teasdale, Andrew

Journal:

Organic Process Research & Development

Year:

2015

Language:

english

File:

PDF, 1.13 MB

english, 2015

19

Alternatives Models in Carcinogenicity Testing--A European Perspective

Laan, Jan Willem van der, Lima, Beatriz Silva, Snodin, David

Journal:

Toxicologic Pathology

Year:

2002

Language:

english

File:

PDF, 75 KB

english, 2002

20

Notes

KATHARINA MAYER HAUNTON, HILARY YOUNG, MICHAEL SNODIN, ANTONY GRIFFITHS, PAT GILMOUR, CHRIS MICHAELIDES, MARTIN HOPKINSON, ELLEN G. D'OENCH, DAVID FLETCHER, RALPH HYDE, JOANNA SELBORNE and SILVIE TURN

Journal:

Print Quarterly

Year:

1998

Language:

english

File:

PDF, 6.59 MB

english, 1998

21

Notes

ANTONY GRIFFITHS, ROBERT HARDING, SIMON TURNER, DAVID ALEXANDER, JEAN MICHEL MASSING, RALPH HYDE, FLAVIA PESCI, PAT GILMOUR, REBA WHITE WILLIAMS, MICHAEL SNODIN, ANTHONY DYSON, JACOB SIMON and DAVID L

Journal:

Print Quarterly

Year:

1998

Language:

english

File:

PDF, 4.37 MB

english, 1998

22

Notes

DAVID ALEXANDER, JEAN MICHEL MASSING, JAN PIET FILEDT KOK, GEOFFREY DOWN, MICHAEL SNODIN, CRAIG HARTLEY, ANTONY GRIFFITHS, ANTOINE CAHEN, DAVID SCHENCK, PAMELA D. KINGSBURY, PAT GILMOUR, KAREN KLOTH a

Journal:

Print Quarterly

Year:

1994

Language:

english

File:

PDF, 7.02 MB

english, 1994

23

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

Snodin, David J., Elder, David P.

Journal:

Regulatory Toxicology and Pharmacology

Year:

2019

Language:

english

File:

PDF, 529 KB

english, 2019

24

Elusive impurities – evidence versus hypothesis. Technical and regulatory update on alkyl sulfonates in sulfonic-acid salts

Snodin, David John

Journal:

Organic Process Research & Development

Year:

2019

Language:

english

File:

PDF, 389 KB

english, 2019

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