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
In Vitro Inhibition of Multiple Cytochrome P450 Isoforms by Xanthone Derivatives from Mangosteen Extract Publication In Vitro Inhibition of Multiple Cytochrome P450 Isoforms by Xanthone Derivatives from Mangosteen Extract Mangosteen is a xanthone-containing fruit found in Southeast Asia for which health claims include maintaining healthy immune…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
Excluding Venous Thromboembolism Using Point of Care D-dimer Tests in Outpatients: A Diagnostic Meta-analysis Publication Excluding Venous Thromboembolism Using Point of Care D-dimer Tests in Outpatients: A Diagnostic Meta-analysis This article is a review the evidence on the diagnostic accuracy of the currently available…CertaraAugust 14, 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
On the Use of Change in Tumor Size to Predict Survival in Clinical Oncology Studies: Toward a New Paradigm to Design and Evaluate Phase 2 Studies Publication On the Use of Change in Tumor Size to Predict Survival in Clinical Oncology Studies: Toward a New Paradigm to Design and Evaluate Phase 2 Studies Drug-independent models that link biomarker response to clinical end points are critical to support early…CertaraAugust 1, 2009