FDA DataFit: an introduction
Explore FDA DataFit, a project ensuring high-quality, compliant data to streamline drug reviews, reduce delays,…
Certara2014年8月19日
FDA JumpStart: an introduction
Discover FDA JumpStart, a ground-breaking service accelerating drug reviews by enhancing data quality, identifying risks,…
Certara2014年7月16日
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…
Certara2014年7月9日
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…
Certara2013年9月1日
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
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
The use of whole body physiological-based pharmacokinetic (PBPK) models linked with in vitro-in vivo extrapolation…
Certara2013年1月1日
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
