(Q37645780)

21 August 2017

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title

Overview of genotoxic impurities in pharmaceutical development (English)

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21 August 2017

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Joel P Bercu

1

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21 August 2017

Krista L Dobo

series ordinal

2

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21 August 2017

Elmar Gocke

series ordinal

3

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21 August 2017

Timothy J McGovern

series ordinal

4

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21 August 2017

publication date

1 November 2009

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International Journal of Toxicology

21 August 2017

published in

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21 August 2017

volume

28

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21 August 2017

issue

6

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21 August 2017

page(s)

468-478

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Structure-based thresholds of toxicological concern (TTC): guidance for application to substances present at low levels in the diet

21 August 2017

cites work

1 reference

https://api.crossref.org/works/10.1177%2F1091581809349195

A procedure for the safety evaluation of flavouring substances. Joint FAO/WHO Expert Committee on Food Additives

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1091581809349195

A tiered approach to threshold of regulation.

21 January 2018

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https://api.crossref.org/works/10.1177%2F1091581809349195

Safety assessment procedures for indirect food additives: an overview. Report of a workshop

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1091581809349195

The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1091581809349195

Mechanistic influences for mutation induction curves after exposure to DNA-reactive carcinogens

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1091581809349195

Biomarkers in toxicology and risk assessment: informing critical dose-response relationships

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1091581809349195

Risk assessment of substances that are both genotoxic and carcinogenic report of an International Conference organized by EFSA and WHO with support of ILSI Europe.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1091581809349195

Risk assessment of peak exposure to genotoxic carcinogens: a pragmatic approach

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1091581809349195

Quantitative assessment of cumulative carcinogenic risk for multiple genotoxic impurities in a new drug substance.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1091581809349195

A practical derivatization LC/MS approach for determination of trace level alkyl sulfonates and dialkyl sulfates genotoxic impurities in drug substances

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1091581809349195

Control and analysis of alkyl and benzyl halides and other related reactive organohalides as potential genotoxic impurities in active pharmaceutical ingredients (APIs).

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1091581809349195

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

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1091581809349195

Analytical control of genotoxic impurities in the pazopanib hydrochloride manufacturing process.

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1091581809349195

An impact analysis of the application of the threshold of toxicological concern concept to pharmaceuticals

21 January 2018

1 reference

https://api.crossref.org/works/10.1177%2F1091581809349195

21 January 2018

Identifiers

DOI

10.1177/1091581809349195

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21 August 2017

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