In silico toxicology protocols

Glenn J. Myatt, Ernst Ahlberg, Yumi Akahori, +80

Regulatory Toxicology and Pharmacology

Toxicology TestingEnvironmental HealthToxicologyBiostatisticsToxicological Aspect +16

The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development

Krista L. Dobo, Nigel Greene, Michelle O. Cyr, +2

Regulatory Toxicology and Pharmacology

Structure-based AssessmentMedicinal ChemistryDrug PurityBioanalysisAnalytical Chemistry +14

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

Andreas Sutter, Alexander Amberg, Scott Boyer, +15

Regulatory Toxicology and Pharmacology

Expert KnowledgeChemical SafetyEngineeringChemical AnalysisSilico Systems +13

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

Alexander Amberg, Lisa Beilke, Joel P. Bercu, +32

Regulatory Toxicology and Pharmacology

EngineeringPathologyImpurity QualificationChemical SafetyImaging Radar +20

In silico methods combined with expert knowledge rule out mutagenic potential of pharmaceutical impurities: An industry survey

Krista L. Dobo, Nigel Greene, Charlotta Fred, +11

Regulatory Toxicology and Pharmacology

Chemical EngineeringResidue (Chemistry)EngineeringMedicineProcess Analytical Technology +13

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

Chris Barber, Alexander Amberg, Laura Custer, +13

Regulatory Toxicology and Pharmacology

Chemical SafetyBest PractiseEngineeringPredictive ToxicologyGenetics +11

Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product <i>N</i>-Nitrosamine Impurities

Krista L. Dobo, Michelle Kenyon, Olivier Dirat, +10

Chemical Research in Toxicology

Genetic toxicology in silico protocol

Catrin Hasselgren, Ernst Ahlberg, Yumi Akahori, +71

Regulatory Toxicology and Pharmacology

EngineeringGeneticsToxicology TestingRegulatory Safety ScienceToxicology +15

Permitted daily exposure limits for noteworthy <i>N‐nitrosamines</i>

George E. Johnson, Krista L. Dobo, B. Bhaskar Gollapudi, +9

Environmental and Molecular Mutagenesis

Defining EMS and ENU dose–response relationships using the Pig-a mutation assay in rats

Krista L. Dobo, Ronald D. Fiedler, William C. Gunther, +5

Mutation Research/Genetic Toxicology and Environmental Mutagenesis

Animal PhysiologyAnimal TestingPig-a Mutation AssayMedicinePhysiology +3