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

Principles and procedures for handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR analyses

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2019-03-0122

OAAI

Amberg, Alexander; Andaya, Roxanne V.; Anger, Lennart T.; Barber, Chris; Beilke, Lisa; Bercu, Joel; Bower, Dave; Brigo, Alessandro; Cammerer, Zoryanna; Cross, Kevin P.; Custer, Laura; Dobo, Krista; Gerets, Helga; Gervais, Veronique; Glowienke, Susanne; Gomez, Stephen; Van Gompel, Jacky; Harvey, James; Hasselgren, Catrin; Honma, Masamitsu; Johnson, Candice; Jolly, Robert; Kemper, Raymond; Kenyon, Michelle; Kruhlak, Naomi; Leavitt, Penny; Miller, Scott; Muster, Wolfgang; Naven, Russell; Nicolette, John; Parenty, Alexis; Powley, Mark; Quigley, Donald P.; Reddy, M. Vijayaraj; Sasaki, Jennifer C.; Stavitskaya, Lidiya; Teasdale, Andrew; Trejo-Martin, Alejandra; Weiner, Sandy; Welch, Dennie S.; White, Angela; Wichard, Joerg; Woolley, David; Myatt, Glenn J.

In silico toxicology protocols

计算机毒理学协议

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2018-07-01153

OAAI

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

Potential impurities in drug substances: Compound-specific toxicology limits for 20 synthetic reagents and by-products, and a class-specific toxicology limit for alkyl bromides

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2018-04-0139

PREAI

Resolution of contradiction between in silico predictions and Ames test results for four pharmaceutically relevant impurities

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2017-12-016

PREAI

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

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2016-06-0182

OAAI

Amberg, Alexander; Beilke, Lisa; Bercu, Joel; Bower, Dave; Brigo, Alessandro; Cross, Kevin P.; Custer, Laura; Dobo, Krista; Dowdy, Eric; Ford, Kevin A.; Glowienke, Susanne; Van Gompel, Jacky; Harvey, James; Hasselgren, Catrin; Honma, Masamitsu; Jolly, Robert; Kemper, Raymond; Kenyon, Michelle; Kruhlak, Naomi; Leavitt, Penny; Miller, Scott; Muster, Wolfgang; Nicolette, John; Plaper, Andreja; Powley, Mark; Quigley, Donald P.; Reddy, M. Vijayaraj; Spirkl, Hans-Peter; Stavitskaya, Lidiya; Teasdale, Andrew; Weiner, Sandy; Welch, Dennie S.; White, Angela; Wichard, Joerg; Myatt, Glenn J.

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

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2015-10-0166

PREAI

A practical application of two in silico systems for identification of potentially mutagenic impurities

两个计算机系统在识别潜在诱变杂质中的实际应用

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2015-07-0139

PREAI

Use of in silico systems and expert knowledge for structure-based assessment of potentially mutagenic impurities