Regulatory Toxicology and Pharmacology, volume 77, pages 13-24

Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses

Alexander Amberg ¹

Lisa D. Beilke ²

Joel Bercu ³

Dave Bower ⁴

Alessandro Brigo ⁵

Kevin P. Cross ⁴

Laura Custer ^{6, 7}

Krista Dobo ⁸

Eric Dowdy ³

Kevin A Ford ^{9, 10}

Susanne Glowienke ¹¹

Jacky Van Gompel ¹²

James S Harvey ¹³

Catrin Hasselgren ⁴

Masamitsu Honma ¹⁴

Robert A Jolly ¹⁵

Raymond Kemper ¹⁶

Michelle Kenyon ⁸

Naomi Kruhlak ¹⁷

Penny Leavitt ^{6, 7}

Scott Miller ⁴

Wolfgang Muster ⁵

John Nicolette ¹⁸

Andreja Plaper ¹⁹

Mark Powley ¹⁷

Donald P Quigley ⁴

M.Vijayaraj Reddy ²⁰

Hans Peter Spirkl ¹

L. Stavitskaya ¹⁷

Andrew Teasdale ²¹

Sandy Weiner ²²

Dennie S Welch ¹⁸

Angela White ¹³

Jörg D Wichard ²³

Glenn J. Myatt ⁴

Show full list: 35 authors

Hide authors affiliations

Sanofi-aventis Deutschland GmbH, Frankfurt, Germany. |

Toxicology Solutions, San Diego, CA, USA. |

Gilead, Foster City, CA, USA. |

⁴

Leadscope, Columbus, OH, USA. |

⁵

Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland. |

⁶

Bristol-Myers Squibb

⁷

New Brunswick NJ USA |

⁸

Pfizer Groton CT USA |

⁹

Genentech

¹⁰

South San Francisco USA |

¹¹

Novartis Institutes for Biomedical Research,Basel,Switzerland |

¹²

Janssen, Beerse, Belgium |

¹³

GlaxoSmithKline, Ware, Herts, UK |

¹⁴

National Institute of Health Sciences, Tokyo, Japan. |

¹⁵

Eli-Lilly and Company, Indianapolis, IN, USA |

¹⁶

Vertex, Boston, MA, USA. |

¹⁷

FDA Center for Drug Evaluation and Research, Silver Spring, MD, USA. |

¹⁸

AbbVie, Inc North Chicago IL USA |

¹⁹

KRKA, Novo Mesto, Slovenia. |

²⁰

Merck Research Laboratories West Point PA USA |

²¹

AstraZeneca, Macclesfield, Cheshire, UK, |

²²

Janssen, Spring House, PA, USA |

²³

Bayer Healthcare, Berlin, Germany. |

Publication type: Journal Article

Publication date: 2016-06-01

Elsevier

Journal: Regulatory Toxicology and Pharmacology

scimago Q2

SJR: 0.778

CiteScore: 6.7

Impact factor: 3

ISSN: 02732300, 10960295

DOI: 10.1016/j.yrtph.2016.02.004

Copy DOI

General Medicine

Toxicology

Abstract

The ICH M7 guideline describes a consistent approach to identify, categorize, and control DNA reactive, mutagenic, impurities in pharmaceutical products to limit the potential carcinogenic risk related to such impurities. This paper outlines a series of principles and procedures to consider when generating (Q)SAR assessments aligned with the ICH M7 guideline to be included in a regulatory submission. In the absence of adequate experimental data, the results from two complementary (Q)SAR methodologies may be combined to support an initial hazard classification. This may be followed by an assessment of additional information that serves as the basis for an expert review to support or refute the predictions. This paper elucidates scenarios where additional expert knowledge may be beneficial, what such an expert review may contain, and how the results and accompanying considerations may be documented. Furthermore, the use of these principles and procedures to yield a consistent and robust (Q)SAR-based argument to support impurity qualification for regulatory purposes is described in this manuscript.

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Publisher

Elsevier

Journal

Regulatory Toxicology and Pharmacology

scimago Q2

SJR

0.778

CiteScore

6.7

Impact factor

ISSN

02732300 (Print)

10960295 (Electronic)

Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses

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