Cardiac Safety Research Consortium: Can the Thorough QT/QTc Study Be Replaced by Early QT Assessment in Routine Clinical Pharmacology Studies? Scientific Update and a Research Proposal for a Path Forward Publication Cardiac Safety Research Consortium: Can the Thorough QT/QTc Study Be Replaced by Early QT Assessment in Routine Clinical Pharmacology Studies? Scientific Update and a Research Proposal for a Path Forward The International Conference on Harmonization E14 guidance for the clinical evaluation of QT/QTc interval prolongation…Danielle Pillsbury2014 年 9 月 1 日
Understanding the Effect of the HCV Polymerase Inhibitor Mericitabine on Early Viral Kinetics in the Phase 2 JUMP-C and PROPEL Studies Publication Understanding the Effect of the HCV Polymerase Inhibitor Mericitabine on Early Viral Kinetics in the Phase 2 JUMP-C and PROPEL Studies Danielle Pillsbury2014 年 8 月 21 日
Adding a Placebo Component to Your PK/PD Model in Phoenix Knowledge Base Adding a Placebo Component to Your PK/PD Model in Phoenix PK/PD modeling is an exciting are of research in clinical pharmacology. Most often we try…Nathan Teuscher2014 年 8 月 20 日
Bioanalytical Calibration Curves Knowledge Base Bioanalytical Calibration Curves At the request of a reader, I have decided to extend my series on bioanalysis…Nathan Teuscher2014 年 8 月 12 日
Assessment of Tumor Growth Inhibition Metrics to Predict Overall Survival Publication Assessment of Tumor Growth Inhibition Metrics to Predict Overall Survival Modeling and simulation is proposed to support drug development phase transitions in oncology. Longitudinal tumor-size…Danielle Pillsbury2014 年 8 月 1 日
Radiometric Analysis Knowledge Base Radiometric Analysis One of the oldest methods used for the quantitation of drug molecules is radiometric analysis.…Nathan Teuscher2014 年 7 月 29 日
Understanding LC/MS/MS BlogKnowledge Base Understanding LC/MS/MS The most common bioanalytical method in use today is LC/MS/MS, or liquid chromatography (LC) tandem…Certara2014 年 7 月 15 日
Population Pharmacokinetic Analysis of Dutogliptin, a Selective Dipeptidyl Peptidase-4 Inhibitor Publication Population Pharmacokinetic Analysis of Dutogliptin, a Selective Dipeptidyl Peptidase-4 Inhibitor Dutogliptin is a selective dipeptidyl peptidase-4 inhibitor shown to be efficacious and safe in patients…Danielle Pillsbury2014 年 7 月 14 日
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…Danielle Pillsbury2014 年 7 月 9 日
What is HPLC/UV? 知识库 What is HPLC/UV? In my series about bioanalysis for the pharmacokineticist, I thought I would start with the…Nathan Teuscher2014 年 7 月 8 日