Robert A. Jolly

lilly research laboratories

H指数:26

被引数:2,515

个人简介

暂无内容

教育背景

暂无内容

工作经历

暂无内容

荣誉奖项

暂无内容

Applicability of the ICH M7 Guidelines for Assessing Less-than-Lifetime Exposure to Nitrosamine Impurities in Drug Products

ICH M7指导原则在评估药物产品中亚硝胺杂质低于一生暴露情况下的适用性

Regulatory Toxicology and Pharmacology

IF3.5

2026-09-110

OAAI

Ames Concordance with the In Vivo Transgenic Rodent (TGR) Gene Mutation Assay for NDSRIs and Relative In Vivo TGR Potency with Nitrosamines with Robust Dose-Response Carcinogenicity Data

Regulatory Toxicology and Pharmacology

IF3.5

2026-01-300

PRE

Assessment and Control of Host Cell Proteins in Biologics: Survey of Industry Practices and a Vision for Harmonization

生物制剂中宿主细胞蛋白的评估和控制: 行业实践调查和协调愿景

BIOTECHNOLOGY AND BIOENGINEERING

IF3.6

2026-01-010

PRE

HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions

HESI GTTC环试：在N-亚硝胺（NAs）的Ames试验与啮齿类动物致癌性结果之间，大鼠和仓鼠代谢条件下的符合性研究

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2025-06-110

OAAI

Bercu, Joel; Trejo-Martin, Alejandra; Chen, Connie; Schuler, Maik; Cheung, Jennifer; Cheairs, Tetyana; Lynch, Anthony M.; Thomas, Dean; Czich, Andreas; Atrakchi, Aisar; Mcgovern, Timothy J.; Heflich, Robert H.; Vespa, Alisa; Froetschl, Roland; Yang, Yi; Gandhi, Raj D.; Elloway, Joanne; Ziegler, Verena; Hellmann, Anna; Schaefer, Michelle; Tennant, Rachael E.; Westerink, Walter; Hoffmans, Roy; Jolly, Robert; Noteboom, Jessica; Gollapudi, Pavan; Sobol, Zhanna; Mcgettigan, Katherine K.; Christensen, Joel S.; Simon, Stephanie; Dieckhoff, Jessica; Zeller, Andreas; Marchand, Christine; Waese, Kerstin; Bishop, Michelle E.; Leavitt, Penny; Hargreaves, Victoria; Glick, Connor; Liao, Yang; Elespuru, Rosalie; Puglisi, Raechel

N-Nitrosamine drug substance related impurities (NDSRIs) - A proposal for the addition of subcategories to carcinogenic potency categorization approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da

N-亚硝胺原料药相关杂质 (NDSRIs) -关于分子量> 200 Da的NDSRIs在致癌性效力分类方法类别1和2中增加子类别的建议

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2024-12-012

PRE

Safety assessment of protein A and derivation of a parenteral health-based exposure limit

蛋白A的安全性评估和基于肠胃外健康的暴露极限的推导

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2024-11-010

OAAI

Estimation of acceptable daily intake values based on modeling and in vivo mutagenicity of NDSRIs of fluoxetine, duloxetine and atomoxetine

基于氟西汀，度洛西汀和托莫西汀的NDSRIs建模和体内致突变性的可接受每日摄入量的估算

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2024-09-013

PRE

Quantum Mechanical Assessment of Nitrosamine Potency

CHEMICAL RESEARCH IN TOXICOLOGY

IF3.8

2024-05-284

PRE

Principles and procedures for assessment of acute toxicity incorporating in silico methods

COMPUTATIONAL TOXICOLOGY

IF2.9

2022-11-018

OAAI

Zwickl, Craig M.; Graham, Jessica C.; Jolly, Robert A.; Bassan, Arianna; Ahlberg, Ernst; Amberg, Alexander; Anger, Lennart T.; Beilke, Lisa; Bellion, Phillip; Brigo, Alessandro; Burleigh-Flayer, Heather; Cronin, Mark T. D.; Devlin, Amy A.; Fish, Trevor; Glowienke, Susanne; Gromek, Kamila; Karmaus, Agnes L.; Kemper, Ray; Kulkarni, Sunil; Lo Piparo, Elena; Madia, Federica; Martin, Matthew; Masuda-Herrera, Melisa; Mcatee, Britt L.; Mestres, Jordi; Milchak, Lawrence; Moudgal, Chandrika; Mumtaz, Moiz; Muster, Wolfgang; Neilson, Louise; Patlewicz, Grace; Paulino, Alexandre; Roncaglioni, Alessandra; Ruiz, Patricia; Szabo, David T.; Valentin, Jean-Pierre; Vardakou, Ioanna; Woolley, David; Myatt, Glenn J.

Setting impurity limits for endogenous substances: Recommendations for a harmonized procedure and an example using fatty acids

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2022-10-010

PRE

Increasing the acceptance of in silico toxicology through development of protocols and position papers

COMPUTATIONAL TOXICOLOGY

IF2.9

2022-02-018

PRE

Skin sensitization in silico protocol

silico协议中的皮肤致敏

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2020-10-0131

OAAI

Johnson, Candice; Ahlberg, Ernst; Anger, Lennart T.; Beilke, Lisa; Benigni, Romualdo; Bercu, Joel; Bobst, Sol; Bower, David; Brigo, Alessandro; Campbell, Sarah; Cronini, Mark T. D.; Crooks, Ian; Cross, Kevin P.; Doktorova, Tatyana; Exner, Thomas; Faulkner, David; Fearon, Ian M.; Fehr, Markus; Gad, Shayne C.; Gervais, Veronique; Giddings, Amanda; Glowienke, Susanne; Hardy, Barry; Hasselgren, Catrin; Hillegass, Jedd; Jolly, Robert; Krupp, Eckart; Lomnitski, Liat; Magby, Jason; Mestres, Jordi; Milchak, Lawrence; Miller, Scott; Muster, Wolfgang; Neilson, Louise; Parakhia, Rahul; Parentys, Alexis; Parris, Patricia; Paulino, Alexandre; Paulino, Ana Theresa; Roberts, David W.; Schlecker, Harald; Stidl, Reinhard; Suarez-Rodrigez, Diana; Szabo, David T.; Tice, Raymond R.; Urbisch, Daniel; Vuorinen, Anna; Wall, Brian; Weiler, Thibaud; White, Angela T.; Whritenour, Jessica; Wichard, Joerg; Woolley, David; Zwickl, Craig; Myatt, Glenn J.

Genetic toxicology in silico protocol

计算机协议中的遗传毒理学

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2019-10-0149

OAAI

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

Issues and approaches for ensuring effective communication on acceptable daily exposure (ADE) values applied to pharmaceutical cleaning

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2016-08-0111

PREAI

A harmonization effort for acceptable daily exposure application to pharmaceutical manufacturing - Operational considerations

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2016-08-0112

PREAI

Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: A case study using aromatic amine mutagenicity

REGULATORY TOXICOLOGY AND PHARMACOLOGY

IF3.5

2016-06-0138

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.

Robert A. Jolly

个人简介

教育背景

工作经历

荣誉奖项

研究方向