Breast Cancer Resistance Protein Abundance, but Not mRNA Expression, Correlates with Estron e-3-Sulfate Transport in Caco-2 Publication Breast Cancer Resistance Protein Abundance, but Not mRNA Expression, Correlates with Estron e-3-Sulfate Transport in Caco-2 Transporter mRNA and protein expression data are used to extrapolate in vitro transporter kinetics to in…Certara2016年4月1日
Population Pharmacokinetic and Pharmacodynamic Analyses from a 4-Month Intra-dose Escalation and Its Subsequent 12-month Dose Titration Studies for a Human Monoclonal Anti-FGF23 Antibody (KRN23) in Adults with X-linked Hypophosphatemia Publication Population Pharmacokinetic and Pharmacodynamic Analyses from a 4-Month Intra-dose Escalation and Its Subsequent 12-month Dose Titration Studies for a Human Monoclonal Anti-FGF23 Antibody (KRN23) in Adults with X-linked Hypophosphatemia X-linked hypophosphatemia (XLH) is an inherited metabolic bone disease with abnormally elevated serum FGF23 resulting…Certara2016年4月1日
A Critical Evaluation of the Experimental Design of Studies of Mechanism-based Enzyme Inhibition, with Implications for In Vitro-In Vivo Extrapolation Publication A Critical Evaluation of the Experimental Design of Studies of Mechanism-based Enzyme Inhibition, with Implications for In Vitro-In Vivo Extrapolation The published literature on mechanism based inhibition (MBI) of CYPs was evaluated with respect to…Certara2016年4月1日
Population Pharmacokinetics and Exposure-response of Trametinib, a MEK Inhibitor, in Patients with BRAF V600 Mutation-positive Melanoma Publication Population Pharmacokinetics and Exposure-response of Trametinib, a MEK Inhibitor, in Patients with BRAF V600 Mutation-positive Melanoma The purpose of this study was to characterize the pharmacokinetics of oral trametinib, a first in…Certara2016年4月1日
Best Practices for Placing Drug Master File Reference Letters in Regulatory Applications Blog Best Practices for Placing Drug Master File Reference Letters in Regulatory Applications Within drug applications (ANDA, BLA, IND, or NDA), eCTD (electronic common technical document) Module 3…Certara2016年3月14日
Pharmacokinetics of a Single Dose of Oral and Subcutaneous Meloxicam in Caribbean Flamingos (Phoenicopterus ruber ruber) Publication Pharmacokinetics of a Single Dose of Oral and Subcutaneous Meloxicam in Caribbean Flamingos (Phoenicopterus ruber ruber) To determine the pharmacokinetics of meloxicam in Caribbean flamingos ( Phoenicopterus ruber ruber), a pilot…Certara2016年3月1日
Drug-drug Interactions and QT Prolongation as a Commonly Assessed Cardiac Effect—Comprehensive Overview of Clinical Trials Publication Drug-drug Interactions and QT Prolongation as a Commonly Assessed Cardiac Effect—Comprehensive Overview of Clinical Trials Certara2016年3月1日
In Vitro-In Vivo Extrapolation Scaling Factors for Intestinal P-glycoprotein and Breast Cancer Resistance Protein: Part I—A Cross-laboratory Comparison of Transporter-protein Abundances and Relative Expression Factors in Human Intestine and Caco-2 Cells Publication In Vitro-In Vivo Extrapolation Scaling Factors for Intestinal P-glycoprotein and Breast Cancer Resistance Protein: Part I—A Cross-laboratory Comparison of Transporter-protein Abundances and Relative Expression Factors in Human Intestine and Caco-2 Cells Over the last 5 years the quantification of transporter-protein absolute abundances has dramatically increased in parallel to the expanded…Certara2016年3月1日
In Vitro-In Vivo Extrapolation Scaling Factors for Intestinal P-glycoprotein and Breast Cancer Resistance Protein: Part II—The Impact of Cross-laboratory Variations of Intestinal Transporter Relative Expression Factors on Predicted Drug Disposition Publication In Vitro-In Vivo Extrapolation Scaling Factors for Intestinal P-glycoprotein and Breast Cancer Resistance Protein: Part II—The Impact of Cross-laboratory Variations of Intestinal Transporter Relative Expression Factors on Predicted Drug Disposition Relative expression factors (REFs) are used to scale in vitro transporter kinetic data via in vitro-in vivo extrapolation linked to physiologically based pharmacokinetic (IVIVE-PBPK)…Certara2016年3月1日
Immune Cell-based Screening Assay for Response to Anticancer Agents: Applications in Pharmacogenomics Publication Immune Cell-based Screening Assay for Response to Anticancer Agents: Applications in Pharmacogenomics Certara2016年2月26日