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Articles (49)

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1-10 of 49 results for genotoxic impurities

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Select article: Overview of Genotoxic Impurities in Pharmaceutical Development

Free access

Review article

First published 2009-11

Overview of Genotoxic Impurities in Pharmaceutical Development

Joel P. Bercu, Krista L. Dobo, Elmar Gocke [...]

International Journal of Toxicology

Select article: Use of Genotoxicity Data to Support Clinical Trials or Positive Genetox Findings on a Candidate Pharmaceutical or Impurity …. Now What?

Free access

Research article

First published 2005-5

Use of Genotoxicity Data to Support Clinical Trials or Positive Genetox Findings on a Candidate Pharmaceutical or Impurity …. Now What?

David Jacobson-Kram, Abigail Jacobs

International Journal of Toxicology

Select article: Acute and Genotoxic Profile of a Dimeric Impurity of Cefotaxime

Free access

Research article

First published 2004-1

Acute and Genotoxic Profile of a Dimeric Impurity of Cefotaxime

Shiv Kumar Agarwal, Upendra Bhatnagar, Navin Rajesh

International Journal of Toxicology

Select article: International Workshop on Qualification and Control of Impurities *

Retricted access

Other

First published 2006-4

International Workshop on Qualification and Control of Impurities *

Leon A.G.J.M Van Aerts, Peter Kasper, Olaf Queckenberg [...]

Therapeutic Innovation & Regulatory Science

Select article: Review of Genotoxic Impurities: Strategies for Identification and Control

Retricted access

Book review

First published 2012-3

Review of Genotoxic Impurities: Strategies for Identification and Control

Theresa Allio

Therapeutic Innovation & Regulatory Science

Select article: Low Level Determinations of Methyl Methanesulfonate and Ethyl Methanesulfonate Impurities in Emtricitabine Active Pharmaceutical Ingredient by LC/MS/MS using Electrospray Ionization

Open access

Research article

First published 2011

Low Level Determinations of Methyl Methanesulfonate and Ethyl Methanesulfonate Impurities in Emtricitabine Active Pharmaceutical Ingredient by LC/MS/MS using Electrospray Ionization

P.R. Kakadiya, T.G. Chandrashekhar, S. Ganguly [...]

Analytical Chemistry Insights

Select article: Development and Regulatory Challenges for Peptide Therapeutics

Free access

Meeting report

First published 2021-3

Development and Regulatory Challenges for Peptide Therapeutics

Doris Zane, Paul L. Feldman, Tomi Sawyer [...]

International Journal of Toxicology

Select article: Comparative evaluation of three methylene dianiline isomers in the bacterial reverse mutation assay,the in vitro gene mutation test,and the in vitro chromosomal aberration test

Open access

Research article

First published 2022-9

Comparative evaluation of three methylene dianiline isomers in the bacterial reverse mutation assay,the in vitro gene mutation test,and the in vitro chromosomal aberration test

Elif Unterberger-Henig

Toxicology and Industrial Health

Select article: Final Report on the Safety Assessment of Dimethyl Lauramine

Free access

Research article

First published 1995-06

Final Report on the Safety Assessment of Dimethyl Lauramine

International Journal of Toxicology

Select article: Amended Final Report On the Safety Assessment of Pentaerythrityl Rosinate

Free access

Research article

First published 1998-2

Amended Final Report On the Safety Assessment of Pentaerythrityl Rosinate

F.A. Andersen

International Journal of Toxicology

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