Population Pharmacokinetics of Teduglutide Following Repeated Subcutaneous Administrations in Healthy Participants and in Patients with Short Bowel Syndrome and Crohn’s Disease Publication Population Pharmacokinetics of Teduglutide Following Repeated Subcutaneous Administrations in Healthy Participants and in Patients with Short Bowel Syndrome and Crohn’s Disease Teduglutide is a GLP-2 analog currently evaluated for the treatment of short bowel syndrome, Crohn's…CertaraJanuary 1, 2010
Prediction of Human Drug and Drug Interactions from Time-dependent Inactivation of CYP3A4 in Primary Hepatocytes Using a Population-based Simulator Publication Prediction of Human Drug and Drug Interactions from Time-dependent Inactivation of CYP3A4 in Primary Hepatocytes Using a Population-based Simulator Time-dependent inactivation (TDI) of human cytochromes P450 3A4 (CYP3A4) is a major cause of clinical…CertaraDecember 1, 2009
Assessment of Inter-individual Variability in Predicted Phenytoin Clearance Publication Assessment of Inter-individual Variability in Predicted Phenytoin Clearance The objective of this study was to assess the inter-individual variability in phenytoin (PHT) clearance…CertaraDecember 1, 2009
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…CertaraDecember 1, 2009
Pre-clinical Assessment of the Absorption, Distribution, Metabolism, and Excretion of GDC-0449 (2-chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide), an Orally Bioavailable Systemic Hedgehog Signaling Pathway Inhibitor Publication Pre-clinical Assessment of the Absorption, Distribution, Metabolism, and Excretion of GDC-0449 (2-chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide), an Orally Bioavailable Systemic Hedgehog Signaling Pathway Inhibitor GDC-0449 (2-chloro-N-(4-chloro-3-(pyridin-2-yl)phenyl)-4-(methylsulfonyl)benzamide) is a potent, selective Hedgehog (Hh) signalling pathway inhibitor being developed for the…CertaraNovember 1, 2009
Is a Thorough QTc Study Necessary? The Role of Modeling and Simulation in Evaluating the QTc Prolongation Potential of Drugs Publication Is a Thorough QTc Study Necessary? The Role of Modeling and Simulation in Evaluating the QTc Prolongation Potential of Drugs Concentration-QT (C-QT) modeling has been conducted for multiple compounds at various stages of development in…CertaraNovember 1, 2009
Understanding CYP2D6 Interactions Publication Understanding CYP2D6 Interactions Owing to the polymorphic nature of CYP2D6, clinically significant issues can arise when drugs rely…CertaraOctober 1, 2009
Prediction of Phase 1 Single-dose Pharmacokinetics Using Recombinant Cytochromes P450 and Physiologically-based Modeling Publication Prediction of Phase 1 Single-dose Pharmacokinetics Using Recombinant Cytochromes P450 and Physiologically-based Modeling 1. Ten compounds from the Merck Research Laboratories pipeline were selected to evaluate the utility…CertaraSeptember 1, 2009
Model-based Prediction of Phase 3 Overall Survival in Colorectal Cancer on the Basis of Phase 2 Tumor Dynamics Publication Model-based Prediction of Phase 3 Overall Survival in Colorectal Cancer on the Basis of Phase 2 Tumor Dynamics We developed a drug-disease simulation model to predict antitumor response and overall survival in phase…CertaraSeptember 1, 2009
Comparison of Different Algorithms for Predicting Clinical Drug-drug Interactions, Based on the Use of CYP3A4 In Vitro Data: Predictions of Compounds as Precipitants of Interaction Publication Comparison of Different Algorithms for Predicting Clinical Drug-drug Interactions, Based on the Use of CYP3A4 In Vitro Data: Predictions of Compounds as Precipitants of Interaction Cytochrome P450 3A4 (CYP3A4) is the most important enzyme in drug metabolism and because it…CertaraAugust 1, 2009