Interplay of Metabolism and Transport in Determining Oral Drug Absorption and Gut Wall Metabolism: A Simulation Assessment Using the “Advanced Dissolution, Absorption, Metabolism (ADAM)” Model Publication Interplay of Metabolism and Transport in Determining Oral Drug Absorption and Gut Wall Metabolism: A Simulation Assessment Using the “Advanced Dissolution, Absorption, Metabolism (ADAM)” Model Bioavailability of orally administered drugs can be influenced by a number of factors including release…CertaraNovember 1, 2015
Introducing OpenCDISC Enterprise 3.0 Announcement Introducing OpenCDISC Enterprise 3.0 Pinnacle 21 is proud to announce the launch of OpenCDISC Enterprise 3.0, which will be…CertaraOctober 27, 2015
Max Kanevsky named to the PharmaVOICE 100 List of the Most Inspiring People Announcement Max Kanevsky named to the PharmaVOICE 100 List of the Most Inspiring People Certara’s Pinnacle 21 is honored to announce that Max Kanevsky, has been named to the…CertaraAugust 5, 2015
Common Misconceptions About Computer System Validation Blog Common Misconceptions About Computer System Validation Drug development professionals frequently use computer systems to help them understand the pharmacokinetics (PK) and…CertaraJanuary 28, 2015
Using Modeling and Simulation to Quantify the PK of an Anti-HIV Drug for Babies Blog Using Modeling and Simulation to Quantify the PK of an Anti-HIV Drug for Babies As a scientist at Certara and proud Dad to my three kids, pediatric drug development…CertaraJanuary 15, 2015
Lost in Centrifugation: Accounting for Transporter Protein Losses in Quantitative Targeted Absolute Proteomics Publication Lost in Centrifugation: Accounting for Transporter Protein Losses in Quantitative Targeted Absolute Proteomics In drug development, considerable efforts are made to extrapolate from in vitro and preclinical findings…CertaraOctober 1, 2014
FDA DataFit: an introduction Blog FDA DataFit: an introduction Explore FDA DataFit, a project ensuring high-quality, compliant data to streamline drug reviews, reduce delays,…CertaraAugust 19, 2014
FDA JumpStart: an introduction Blog FDA JumpStart: an introduction Discover FDA JumpStart, a ground-breaking service accelerating drug reviews by enhancing data quality, identifying risks,…CertaraJuly 16, 2014
Application of a Physiologically-based Pharmacokinetic Model to Predict OATP1B1-related Variability in Pharmacodynamics of Rosuvastatin Publication Application of a Physiologically-based Pharmacokinetic Model to Predict OATP1B1-related Variability in Pharmacodynamics of Rosuvastatin Typically, pharmacokinetic-pharmacodynamic (PK/PD) models use plasma concentration as the input that drives the PD model. However, interindividual variability in…CertaraJuly 9, 2014
Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part I—Digoxin Pharmacokinetic Incorporating P-glycoprotein-mediated Efflux Publication Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part I—Digoxin Pharmacokinetic Incorporating P-glycoprotein-mediated Efflux A prerequisite for the prediction of the magnitude of P-glycoprotein (P-gp)-mediated drug-drug interactions between digoxin…CertaraSeptember 1, 2013