Prediction of Altered Bile Acid Disposition Due to Inhibition of Multiple Transporters: An Integrated Approach Using Sandwich-cultured Hepatocytes, Mechanistic Modeling, and Simulation Publication Prediction of Altered Bile Acid Disposition Due to Inhibition of Multiple Transporters: An Integrated Approach Using Sandwich-cultured Hepatocytes, Mechanistic Modeling, and Simulation CertaraAugust 1, 2016
Model-based Meta-analysis: An Innovative Methodology Comes of Age White Paper Model-based Meta-analysis: An Innovative Methodology Comes of Age MBMA integrates internal and external drug development data to inform proprietary commercial and R&D decisions.…CertaraJuly 14, 2016
Phase 1 Study Assessing the Pharmacokinetic Profile and Safety of Avibactam in Patients with Renal Impairment Publication Phase 1 Study Assessing the Pharmacokinetic Profile and Safety of Avibactam in Patients with Renal Impairment Avibactam is a non-β-lactam β-lactamase inhibitor intended for use as a fixed-dose combination with ceftazidime…CertaraJuly 12, 2016
More Power to OATP1B1: An Evaluation of Sample Size in Pharmacogenetic Studies Using a Rosuvastatin PBPK Model for Intestinal, Hepatic, and Renal Transporter-mediated Clearances Publication More Power to OATP1B1: An Evaluation of Sample Size in Pharmacogenetic Studies Using a Rosuvastatin PBPK Model for Intestinal, Hepatic, and Renal Transporter-mediated Clearances Rosuvastatin is a substrate of choice in clinical studies of organic anion-transporting polypeptide (OATP)1B1- and…CertaraJuly 1, 2016
Pharmacokinetic Profile of Defibrotide in Patients with Renal Impairment Publication Pharmacokinetic Profile of Defibrotide in Patients with Renal Impairment Hepatic veno-occlusive disease, also called sinusoidal obstruction syndrome (VOD/SOS), is an unpredictable, potentially life-threatening complication…CertaraJune 11, 2016
Diving into Best Practices for Pooling Clinical Trial Data Blog Diving into Best Practices for Pooling Clinical Trial Data Learn the best practices for pooling clinical trial data. Discover how effective data integration enhances…CertaraJune 3, 2016
Lessons Learned: Dose Selection of Small Molecule-targeted Oncology Drugs Publication Lessons Learned: Dose Selection of Small Molecule-targeted Oncology Drugs CertaraJune 1, 2016
Pharmacokinetics and Tissue Elimination of Funixin in Veal Calves Publication Pharmacokinetics and Tissue Elimination of Funixin in Veal Calves OBJECTIVE To describe plasma pharmacokinetic parameters and tissue elimination of flunixin in veal calves. ANIMALS…CertaraJune 1, 2016
Development of a Permeability-limited Model of the Human Brain and Cerebrospinal Fluid (CSF) to Integrate Known Physiological and Biological Knowledge: Estimating Time Varying CSF Drug Concentrations and Their Variability Using In Vitro Data Publication Development of a Permeability-limited Model of the Human Brain and Cerebrospinal Fluid (CSF) to Integrate Known Physiological and Biological Knowledge: Estimating Time Varying CSF Drug Concentrations and Their Variability Using In Vitro Data A 4-compartment permeability-limited brain (4Brain) model consisting of brain blood, brain mass, cranial and spinal…CertaraJune 1, 2016
Metformin and Cimetidine: Physiologically-based Pharmacokinetic Modeling to Investigate Transporter Mediated Drug–drug Interactions Publication Metformin and Cimetidine: Physiologically-based Pharmacokinetic Modeling to Investigate Transporter Mediated Drug–drug Interactions CertaraJune 1, 2016