TOXICOLOGY SUITES

The BioEpisteme® Toxicology Suites are QSAR models that predict major preclinical and clinical toxicological endpoints for drug development and approval. These suites, developed in collaboration with the FDA-CDER (Center for Drug Evaluation and Research), predict adverse effects and off-target activities.

The Preclinical Safety Suites (69 models and 175 submodels) include rodent carcinogenicity, reproductive toxicity, developmental toxicity, fetal developmental toxicity, fetal survival toxicity, behavioral toxicity and genetic toxicity.

The Human Adverse Effects/Clinical Suite includes 23 models and 72 submodels covering adverse cardiological effects, hepatobiliary effects and urinary system effects in humans.

See publications on BioEpisteme® ».

Below is a summary of our discovery toxicology models:

PRECLINICAL Predictive Toxicology (60 model groups)

  • Rodent Carcinogenicity (6 model groups)
  • Rodent MTD (4 model groups)
  • Reproductive Toxicity (7 model groups)
  • Fetal Development Toxicity (8 model groups)
  • Fetal Survival Toxicity (12 model groups)
  • Behavioral Toxicity (3 model groups)
  • Genetic Toxicity Gene Mutation (12 model groups, including AMES)
  • Genetic Toxicity DNA (3 model types)
  • Genetic Toxicity Clastogenicity (5 model types)

CLINICAL Predictive Toxicology
(11 Human model types)

  • Human Adverse Cardiological Effects
  • Human Cardiac Conduction Disorders
  • Human Cardiac Coronary Artery Disorders
  • Human Cardiac Electrocardiogram Disorders
  • Human Cardiac Arrhythmia Disorders
  • Human Cardiac Bradycardia Disorders
  • Human Cardiac QT Prolongation
  • Human Cardiac Tachycardia Disorders
  • Human Cardiac Torsades (based on new clinical data)
  • Human Cardiac Myocardial Infarction Disorders
  • Human Cardiac Palpitations
  • Human Cardiac Rate Rhythm Disorders
  • Human Adverse Phospholipidosis Effects (new endpoint model)
  • Human Adverse Hepatobiliary Effects
    (6 human model types)
  • Human Bile Duct Disorders
  • Human Gall Bladder Disorders
  • Human Liver Jaundice Disorders
  • Human Liver Acute Damage Disorders
  • Human Liver Enzyme Release Disorders
  • Human Hepatotoxicity Disorders (pending)
  • Human Adverse Urinary System Effects
    (6 human model types)
  • Human Bladder Disorders
  • Human Blood in Urine Disorders
  • Human Kidney Disorders
  • Human Kidney Function Tests
  • Human Nephropathy Disorders
  • Human Urolithiasis Disorders