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
Inside the Mind of Pharmacometrics Pioneer, Professor Malcolm Rowland Blog Inside the Mind of Pharmacometrics Pioneer, Professor Malcolm Rowland Officially, Prof. Malcolm Rowland has retired. This scientific pioneer has been helping lay the foundation…Certara2016 年 2 月 23 日