Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part II—Prediction of P-glycoprotein Mediated Drug-drug Interactions with Digoxin Publication Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part II—Prediction of P-glycoprotein Mediated Drug-drug Interactions with Digoxin Digoxin is the recommended substrate for assessment of P-glycoprotein (P-gp)-mediated drug-drug interactions (DDIs) in vivo.…Certara2013 年 9 月 1 日
Clinical Trial Simulation to Inform Phase 2: Comparison of Concentrated vs. Distributed First-in-patient Study Designs in Psoriasis Publication Clinical Trial Simulation to Inform Phase 2: Comparison of Concentrated vs. Distributed First-in-patient Study Designs in Psoriasis Clinical trial simulation (CTS) and model-based meta-analysis (MBMA) can increase our understanding of small, first-in-patient…Certara2013 年 7 月 24 日
A Mechanistic Framework for In Vitro-In Vivo Extrapolation of Liver Membrane Transporters: Prediction of Drug-drug Interaction Between Rosuvastatin and Cyclosporine Publication A Mechanistic Framework for In Vitro-In Vivo Extrapolation of Liver Membrane Transporters: Prediction of Drug-drug Interaction Between Rosuvastatin and Cyclosporine The interplay between liver metabolizing enzymes and transporters is a complex process involving system-related parameters such as liver blood perfusion…Certara2013 年 7 月 24 日
Absolute Abundance and Function of Intestinal Drug Transporters: A Prerequisite for Fully Mechanistic In Vitro-In Vivo Extrapolation of Oral Drug Absorption Publication Absolute Abundance and Function of Intestinal Drug Transporters: A Prerequisite for Fully Mechanistic In Vitro-In Vivo Extrapolation of Oral Drug Absorption The use of whole body physiological-based pharmacokinetic (PBPK) models linked with in vitro-in vivo extrapolation…Certara2013 年 1 月 1 日
Pharmacology and Safety of Glycerol Phenylbutyrate in Healthy Adults and Adults with Cirrhosis Publication Pharmacology and Safety of Glycerol Phenylbutyrate in Healthy Adults and Adults with Cirrhosis Phenylbutyric acid (PBA), which is approved for treatment of urea cycle disorders (UCDs) as sodium…Certara2010 年 6 月 1 日
Clinical Trial Simulations in Pediatric Patients Using Realistic Covariates: Application to Teduglutide, a Glucagon-like Peptide-2 Analog in Neonates and Infants with Short-bowel Syndrome Publication Clinical Trial Simulations in Pediatric Patients Using Realistic Covariates: Application to Teduglutide, a Glucagon-like Peptide-2 Analog in Neonates and Infants with Short-bowel Syndrome Teduglutide, a synthetic glucagon-like peptide-2 (GLP-2) analog with activity relating to the regeneration, maintenance, and…Certara2009 年 12 月 1 日
Population-based Mechanistic Prediction of Oral Drug Absorption Publication Population-based Mechanistic Prediction of Oral Drug Absorption The bioavailability of drugs from oral formulations is influenced by many physiological factors including gastrointestinal…Certara2009 年 6 月 1 日
Enriched Analgesic Efficacy Studies: An Assessment by Clinical Trial Simulation Publication Enriched Analgesic Efficacy Studies: An Assessment by Clinical Trial Simulation The aim of this study was to develop a pain relief model for a cyclooxygenase…Certara2006 年 4 月 1 日
The Use of Clinical Trial Simulation to Support Dose Selection: Application to Development of a New Treatment for Chronic Neuropathic Pain Publication The Use of Clinical Trial Simulation to Support Dose Selection: Application to Development of a New Treatment for Chronic Neuropathic Pain Pregabalin is being evaluated for the treatment of neuropathic pain. Two phase 2 studies were…Certara2003 年 11 月 1 日