Literature DB >> 26248005

Establishing best practise in the application of expert review of mutagenicity under ICH M7.

Chris Barber1, Alexander Amberg2, Laura Custer3, Krista L Dobo4, Susanne Glowienke5, Jacky Van Gompel6, Steve Gutsell7, Jim Harvey8, Masamitsu Honma9, Michelle O Kenyon4, Naomi Kruhlak10, Wolfgang Muster11, Lidiya Stavitskaya10, Andrew Teasdale12, Jonathan Vessey13, Joerg Wichard14.   

Abstract

The ICH M7 guidelines for the assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals allows for the consideration of in silico predictions in place of in vitro studies. This represents a significant advance in the acceptance of (Q)SAR models and has resulted from positive interactions between modellers, regulatory agencies and industry with a shared purpose of developing effective processes to minimise risk. This paper discusses key scientific principles that should be applied when evaluating in silico predictions with a focus on accuracy and scientific rigour that will support a consistent and practical route to regulatory submission.
Copyright © 2015 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Ames; Expert rule-based; Genotoxicity; ICH M7; In silico; Mutagenicity; Statistical

Mesh：

Substances：

Year:  2015        PMID： 26248005     DOI： 10.1016/j.yrtph.2015.07.018

Source DB:  PubMed          Journal:  Regul Toxicol Pharmacol        ISSN： 0273-2300            Impact factor:   3.271


  12 in total

1.  In silico toxicology protocols.

Authors:  Glenn J Myatt; Ernst Ahlberg; Yumi Akahori; David Allen; Alexander Amberg; Lennart T Anger; Aynur Aptula; Scott Auerbach; Lisa Beilke; Phillip Bellion; Romualdo Benigni; Joel Bercu; Ewan D Booth; Dave Bower; Alessandro Brigo; Natalie Burden; Zoryana Cammerer; Mark T D Cronin; Kevin P Cross; Laura Custer; Magdalena Dettwiler; Krista Dobo; Kevin A Ford; Marie C Fortin; Samantha E Gad-McDonald; Nichola Gellatly; Véronique Gervais; Kyle P Glover; Susanne Glowienke; Jacky Van Gompel; Steve Gutsell; Barry Hardy; James S Harvey; Jedd Hillegass; Masamitsu Honma; Jui-Hua Hsieh; Chia-Wen Hsu; Kathy Hughes; Candice Johnson; Robert Jolly; David Jones; Ray Kemper; Michelle O Kenyon; Marlene T Kim; Naomi L Kruhlak; Sunil A Kulkarni; Klaus Kümmerer; Penny Leavitt; Bernhard Majer; Scott Masten; Scott Miller; Janet Moser; Moiz Mumtaz; Wolfgang Muster; Louise Neilson; Tudor I Oprea; Grace Patlewicz; Alexandre Paulino; Elena Lo Piparo; Mark Powley; Donald P Quigley; M Vijayaraj Reddy; Andrea-Nicole Richarz; Patricia Ruiz; Benoit Schilter; Rositsa Serafimova; Wendy Simpson; Lidiya Stavitskaya; Reinhard Stidl; Diana Suarez-Rodriguez; David T Szabo; Andrew Teasdale; Alejandra Trejo-Martin; Jean-Pierre Valentin; Anna Vuorinen; Brian A Wall; Pete Watts; Angela T White; Joerg Wichard; Kristine L Witt; Adam Woolley; David Woolley; Craig Zwickl; Catrin Hasselgren
Journal:  Regul Toxicol Pharmacol       Date:  2018-04-17       Impact factor: 3.271

2.  Genetic toxicology in silico protocol.

Authors:  Catrin Hasselgren; Ernst Ahlberg; Yumi Akahori; Alexander Amberg; Lennart T Anger; Franck Atienzar; Scott Auerbach; Lisa Beilke; Phillip Bellion; Romualdo Benigni; Joel Bercu; Ewan D Booth; Dave Bower; Alessandro Brigo; Zoryana Cammerer; Mark T D Cronin; Ian Crooks; Kevin P Cross; Laura Custer; Krista Dobo; Tatyana Doktorova; David Faulkner; Kevin A Ford; Marie C Fortin; Markus Frericks; Samantha E Gad-McDonald; Nichola Gellatly; Helga Gerets; Véronique Gervais; Susanne Glowienke; Jacky Van Gompel; James S Harvey; Jedd Hillegass; Masamitsu Honma; Jui-Hua Hsieh; Chia-Wen Hsu; Tara S Barton-Maclaren; Candice Johnson; Robert Jolly; David Jones; Ray Kemper; Michelle O Kenyon; Naomi L Kruhlak; Sunil A Kulkarni; Klaus Kümmerer; Penny Leavitt; Scott Masten; Scott Miller; Chandrika Moudgal; Wolfgang Muster; Alexandre Paulino; Elena Lo Piparo; Mark Powley; Donald P Quigley; M Vijayaray Reddy; Andrea-Nicole Richarz; Benoit Schilter; Ronald D Snyder; Lidiya Stavitskaya; Reinhard Stidl; David T Szabo; Andrew Teasdale; Raymond R Tice; Alejandra Trejo-Martin; Anna Vuorinen; Brian A Wall; Pete Watts; Angela T White; Joerg Wichard; Kristine L Witt; Adam Woolley; David Woolley; Craig Zwickl; Glenn J Myatt
Journal:  Regul Toxicol Pharmacol       Date:  2019-06-11       Impact factor: 3.271

3.  Implementation of in silico toxicology protocols within a visual and interactive hazard assessment platform.

Authors:  Glenn J Myatt; Arianna Bassan; Dave Bower; Candice Johnson; Scott Miller; Manuela Pavan; Kevin P Cross
Journal:  Comput Toxicol       Date:  2021-10-28

4.  Use of Lhasa Limited Products for the In Silico Prediction of Drug Toxicity.

Authors:  David J Ponting; Michael J Burns; Robert S Foster; Rachel Hemingway; Grace Kocks; Donna S MacMillan; Andrew L Shannon-Little; Rachael E Tennant; Jessica R Tidmarsh; David J Yeo
Journal:  Methods Mol Biol       Date:  2022

5.  Transitioning to composite bacterial mutagenicity models in ICH M7 (Q)SAR analyses.

Authors:  Curran Landry; Marlene T Kim; Naomi L Kruhlak; Kevin P Cross; Roustem Saiakhov; Suman Chakravarti; Lidiya Stavitskaya
Journal:  Regul Toxicol Pharmacol       Date:  2019-10-03       Impact factor: 3.271

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

Authors:  Alexander Amberg; Lennart T Anger; Joel Bercu; David Bower; Kevin P Cross; Laura Custer; James S Harvey; Catrin Hasselgren; Masamitsu Honma; Candice Johnson; Robert Jolly; Michelle O Kenyon; Naomi L Kruhlak; Penny Leavitt; Donald P Quigley; Scott Miller; David Snodin; Lidiya Stavitskaya; Andrew Teasdale; Alejandra Trejo-Martin; Angela T White; Joerg Wichard; Glenn J Myatt
Journal:  Mutagenesis       Date:  2019-03-06       Impact factor: 3.000

7.  A cross-industry collaboration to assess if acute oral toxicity (Q)SAR models are fit-for-purpose for GHS classification and labelling.

Authors:  Joel Bercu; Melisa J Masuda-Herrera; Alejandra Trejo-Martin; Catrin Hasselgren; Jean Lord; Jessica Graham; Matthew Schmitz; Lawrence Milchak; Colin Owens; Surya Hari Lal; Richard Marchese Robinson; Sarah Whalley; Phillip Bellion; Anna Vuorinen; Kamila Gromek; William A Hawkins; Iris van de Gevel; Kathleen Vriens; Raymond Kemper; Russell Naven; Pierre Ferrer; Glenn J Myatt
Journal:  Regul Toxicol Pharmacol       Date:  2020-12-17       Impact factor: 3.271

8.  Translating New Science Into the Drug Review Process: The US FDA's Division of Applied Regulatory Science.

Authors:  Rodney Rouse; Naomi Kruhlak; James Weaver; Keith Burkhart; Vikram Patel; David G Strauss
Journal:  Ther Innov Regul Sci       Date:  2017-07-21       Impact factor: 1.778

9.  Improvement of quantitative structure-activity relationship (QSAR) tools for predicting Ames mutagenicity: outcomes of the Ames/QSAR International Challenge Project.

Authors:  Masamitsu Honma; Airi Kitazawa; Alex Cayley; Richard V Williams; Chris Barber; Thierry Hanser; Roustem Saiakhov; Suman Chakravarti; Glenn J Myatt; Kevin P Cross; Emilio Benfenati; Giuseppa Raitano; Ovanes Mekenyan; Petko Petkov; Cecilia Bossa; Romualdo Benigni; Chiara Laura Battistelli; Alessandro Giuliani; Olga Tcheremenskaia; Christine DeMeo; Ulf Norinder; Hiromi Koga; Ciloy Jose; Nina Jeliazkova; Nikolay Kochev; Vesselina Paskaleva; Chihae Yang; Pankaj R Daga; Robert D Clark; James Rathman
Journal:  Mutagenesis       Date:  2019-03-06       Impact factor: 3.000

Review 10.  In silico prediction of toxicity and its applications for chemicals at work.

Authors:  Kyung-Taek Rim
Journal:  Toxicol Environ Health Sci       Date:  2020-05-14
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