Meropenem in Children Receiving Continuous Renal Replacement Therapy: Clinical Trial Simulations Using Realistic Covariates
Meropenem is frequently prescribed in children receiving continuous renal replacement therapy (CRRT). Fluid overload is…
webdevDecember 1, 2014
Vigabatrin Pediatric Dosing Information for Refractory Complex Partial Seizures: Results from a Population Dose-response Analysis
We predicted vigabatrin dosages for adjunctive therapy for pediatric patients with refractory complex partial seizures…
webdevDecember 1, 2014
Modeling and Simulation for Medical Product Development and Evaluation: Highlights from the FDA-C-Path-ISOP 2013 Workshop
Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration…
webdevDecember 1, 2014
Population Pharmacokinetics Analysis of Vigabatrin in Adults and Children with Epilepsy and Children with Infantile Spasms
Vigabatrin is an inhibitor of γ-aminobutyric acid transaminase. The purpose of these analyses was to…
webdevNovember 1, 2014
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…
webdevOctober 1, 2014
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…
webdevOctober 1, 2014
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…
webdevSeptember 1, 2014
