pre-update Archives

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

Publication

Time Course of Bone Mineral Density Changes with Denosumab Compared with Other Drugs in Postmenopausal Osteoporosis: A Dose-response-based Meta-analysis

Our objective was to compare the time course of bone mineral density (BMD) changes at…

CertaraOctober 1, 2014

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…

CertaraSeptember 1, 2014

Publication

Deciding on Success Criteria for Predictability of Pharmacokinetic Parameters from In Vitro Studies: An Analysis Based on In Vivo Observations

Prediction accuracy of pharmacokinetic parameters is often assessed using prediction fold error, i.e., being within 2-, 3-, or…

CertaraSeptember 1, 2014

Publication

Development of Physiologically-based Pharmacokinetic Model to Evaluate the Relative Systemic Exposure to Quetiapine After Administration of IR and XR Formulations to Adults, Children, and Adolescents

Quetiapine is an atypical antipsychotic drug with a high permeability, moderate solubility and defined as…

CertaraSeptember 1, 2014

Publication

Understanding the Effect of the HCV Polymerase Inhibitor Mericitabine on Early Viral Kinetics in the Phase 2 JUMP-C and PROPEL Studies

CertaraAugust 21, 2014

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…

CertaraAugust 20, 2014

Publication

Lack of Angiopoietin-like-2 Expression Limits the Metabolic Stress Induced by a High-fat Diet and Maintains Endothelial Function in Mice

Angiopoietin-like-2 (angptl2) is produced by several cell types including endothelial cells, adipocytes and macrophages, and…

CertaraAugust 15, 2014

Knowledge Base

Bioanalytical Calibration Curves

At the request of a reader, I have decided to extend my series on bioanalysis…

CertaraAugust 12, 2014

Publication

Comparative Benefit of Malaria Chemoprophylaxis Modeled in United Kingdom Travelers

CertaraAugust 5, 2014

pre-update

Lost in Centrifugation: Accounting for Transporter Protein Losses in Quantitative Targeted Absolute Proteomics

Time Course of Bone Mineral Density Changes with Denosumab Compared with Other Drugs in Postmenopausal Osteoporosis: A Dose-response-based Meta-analysis

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

Deciding on Success Criteria for Predictability of Pharmacokinetic Parameters from In Vitro Studies: An Analysis Based on In Vivo Observations

Development of Physiologically-based Pharmacokinetic Model to Evaluate the Relative Systemic Exposure to Quetiapine After Administration of IR and XR Formulations to Adults, Children, and Adolescents

Understanding the Effect of the HCV Polymerase Inhibitor Mericitabine on Early Viral Kinetics in the Phase 2 JUMP-C and PROPEL Studies

Adding a Placebo Component to Your PK/PD Model in Phoenix

Lack of Angiopoietin-like-2 Expression Limits the Metabolic Stress Induced by a High-fat Diet and Maintains Endothelial Function in Mice

Bioanalytical Calibration Curves

Comparative Benefit of Malaria Chemoprophylaxis Modeled in United Kingdom Travelers

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