160 related articles for article (PubMed ID: 26248005)
1. Establishing best practise in the application of expert review of mutagenicity under ICH M7.
Barber C; Amberg A; Custer L; Dobo KL; Glowienke S; Van Gompel J; Gutsell S; Harvey J; Honma M; Kenyon MO; Kruhlak N; Muster W; Stavitskaya L; Teasdale A; Vessey J; Wichard J
Regul Toxicol Pharmacol; 2015 Oct; 73(1):367-77. PubMed ID: 26248005
[TBL] [Abstract][Full Text] [Related]
2. Transitioning to composite bacterial mutagenicity models in ICH M7 (Q)SAR analyses.
Landry C; Kim MT; Kruhlak NL; Cross KP; Saiakhov R; Chakravarti S; Stavitskaya L
Regul Toxicol Pharmacol; 2019 Dec; 109():104488. PubMed ID: 31586682
[TBL] [Abstract][Full Text] [Related]
3. Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses.
Amberg A; Beilke L; Bercu J; Bower D; Brigo A; Cross KP; Custer L; Dobo K; Dowdy E; Ford KA; Glowienke S; Van Gompel J; Harvey J; Hasselgren C; Honma M; Jolly R; Kemper R; Kenyon M; Kruhlak N; Leavitt P; Miller S; Muster W; Nicolette J; Plaper A; Powley M; Quigley DP; Reddy MV; Spirkl HP; Stavitskaya L; Teasdale A; Weiner S; Welch DS; White A; Wichard J; Myatt GJ
Regul Toxicol Pharmacol; 2016 Jun; 77():13-24. PubMed ID: 26877192
[TBL] [Abstract][Full Text] [Related]
4. A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategies.
Barber C; Antonucci V; Baumann JC; Brown R; Covey-Crump E; Elder D; Elliott E; Fennell JW; Gallou F; Ide ND; Jordine G; Kallemeyn JM; Lauwers D; Looker AR; Lovelle LE; McLaughlin M; Molzahn R; Ott M; Schils D; Oestrich RS; Stevenson N; Talavera P; Teasdale A; Urquhart MW; Varie DL; Welch D
Regul Toxicol Pharmacol; 2017 Nov; 90():22-28. PubMed ID: 28822875
[TBL] [Abstract][Full Text] [Related]
5. Carbamates and ICH M7 classification: Making use of expert knowledge.
Hemingway R; Fowkes A; Williams RV
Regul Toxicol Pharmacol; 2017 Jun; 86():392-401. PubMed ID: 28385577
[TBL] [Abstract][Full Text] [Related]
6. The Consultancy Activity on In Silico Models for Genotoxic Prediction of Pharmaceutical Impurities.
Pavan M; Kovarich S; Bassan A; Broccardo L; Yang C; Fioravanzo E
Methods Mol Biol; 2016; 1425():511-29. PubMed ID: 27311479
[TBL] [Abstract][Full Text] [Related]
7. In silico prediction of genotoxicity.
Wichard JD
Food Chem Toxicol; 2017 Aug; 106(Pt B):595-599. PubMed ID: 27979779
[TBL] [Abstract][Full Text] [Related]
8. Mutagenicity assessment strategy for pharmaceutical intermediates to aid limit setting for occupational exposure.
Araya S; Lovsin-Barle E; Glowienke S
Regul Toxicol Pharmacol; 2015 Nov; 73(2):515-20. PubMed ID: 26454093
[TBL] [Abstract][Full Text] [Related]
9. Assessing the impact of expert knowledge on ICH M7 (Q)SAR predictions. Is expert review still needed?
Jayasekara PS; Skanchy SK; Kim MT; Kumaran G; Mugabe BE; Woodard LE; Yang J; Zych AJ; Kruhlak NL
Regul Toxicol Pharmacol; 2021 Oct; 125():105006. PubMed ID: 34273441
[TBL] [Abstract][Full Text] [Related]
10. Use of In Silico Methods for Regulatory Toxicological Assessment of Pharmaceutical Impurities.
Kovarich S; Cappelli CI
Methods Mol Biol; 2022; 2425():537-560. PubMed ID: 35188646
[TBL] [Abstract][Full Text] [Related]
11. Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: A case study using aromatic amine mutagenicity.
Ahlberg E; Amberg A; Beilke LD; Bower D; Cross KP; Custer L; Ford KA; Van Gompel J; Harvey J; Honma M; Jolly R; Joossens E; Kemper RA; Kenyon M; Kruhlak N; Kuhnke L; Leavitt P; Naven R; Neilan C; Quigley DP; Shuey D; Spirkl HP; Stavitskaya L; Teasdale A; White A; Wichard J; Zwickl C; Myatt GJ
Regul Toxicol Pharmacol; 2016 Jun; 77():1-12. PubMed ID: 26879463
[TBL] [Abstract][Full Text] [Related]
12. It's difficult, but important, to make negative predictions.
Williams RV; Amberg A; Brigo A; Coquin L; Giddings A; Glowienke S; Greene N; Jolly R; Kemper R; O'Leary-Steele C; Parenty A; Spirkl HP; Stalford SA; Weiner SK; Wichard J
Regul Toxicol Pharmacol; 2016 Apr; 76():79-86. PubMed ID: 26785392
[TBL] [Abstract][Full Text] [Related]
13. Resolution of contradiction between in silico predictions and Ames test results for four pharmaceutically relevant impurities.
Gunther WC; Kenyon MO; Cheung JR; Dugger RW; Dobo KL
Regul Toxicol Pharmacol; 2017 Dec; 91():68-76. PubMed ID: 29061373
[TBL] [Abstract][Full Text] [Related]
14.
Benigni R; Bassan A; Pavan M
Expert Opin Drug Metab Toxicol; 2020 Aug; 16(8):651-662. PubMed ID: 32567390
[TBL] [Abstract][Full Text] [Related]
15. Utility of published DNA reactivity alerts.
Myden A; Guesne SJ; Cayley A; Williams RV
Regul Toxicol Pharmacol; 2017 Aug; 88():77-86. PubMed ID: 28549899
[TBL] [Abstract][Full Text] [Related]
16. Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analyses.
Amberg A; Andaya RV; Anger LT; Barber C; Beilke L; Bercu J; Bower D; Brigo A; Cammerer Z; Cross KP; Custer L; Dobo K; Gerets H; Gervais V; Glowienke S; Gomez S; Van Gompel J; Harvey J; Hasselgren C; Honma M; Johnson C; Jolly R; Kemper R; Kenyon M; Kruhlak N; Leavitt P; Miller S; Muster W; Naven R; Nicolette J; Parenty A; Powley M; Quigley DP; Reddy MV; Sasaki JC; Stavitskaya L; Teasdale A; Trejo-Martin A; Weiner S; Welch DS; White A; Wichard J; Woolley D; Myatt GJ
Regul Toxicol Pharmacol; 2019 Mar; 102():53-64. PubMed ID: 30562600
[TBL] [Abstract][Full Text] [Related]
17. Management of pharmaceutical ICH M7 (Q)SAR predictions - The impact of model updates.
Hasselgren C; Bercu J; Cayley A; Cross K; Glowienke S; Kruhlak N; Muster W; Nicolette J; Reddy MV; Saiakhov R; Dobo K
Regul Toxicol Pharmacol; 2020 Dec; 118():104807. PubMed ID: 33058939
[TBL] [Abstract][Full Text] [Related]
18. A practice of expert review by read-across using QSAR Toolbox.
Fukuchi J; Kitazawa A; Hirabayashi K; Honma M
Mutagenesis; 2019 Mar; 34(1):49-54. PubMed ID: 30690463
[TBL] [Abstract][Full Text] [Related]
19. Comparative evaluation of 11 in silico models for the prediction of small molecule mutagenicity: role of steric hindrance and electron-withdrawing groups.
Ford KA; Ryslik G; Chan BK; Lewin-Koh SC; Almeida D; Stokes M; Gomez SR
Toxicol Mech Methods; 2017 Jan; 27(1):24-35. PubMed ID: 27813437
[TBL] [Abstract][Full Text] [Related]
20. Assessing the utility of common arguments used in expert review of in silico predictions as part of ICH M7 assessments.
Cayley AN; Foster RS; Brigo A; Muster W; Musso A; Kenyon MO; Parris P; White AT; Cohen-Ohana M; Nudelman R; Glowienke S
Regul Toxicol Pharmacol; 2023 Oct; 144():105490. PubMed ID: 37659712
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]