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…CertaraMarch 14, 2016
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…CertaraMarch 1, 2016
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 CertaraMarch 1, 2016
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…CertaraMarch 1, 2016
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)…CertaraMarch 1, 2016
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 CertaraFebruary 26, 2016
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…CertaraFebruary 23, 2016
How LC-MS Proteomics Is Revolutionizing PBPK Modeling and Simulation On-Demand Webinar How LC-MS Proteomics Is Revolutionizing PBPK Modeling and Simulation Drug-metabolizing enzymes and drug transporters play an important role in hepatic drug metabolism and disposition…CertaraFebruary 18, 2016
How Modeling and Simulation Can Bring New Immuno-oncology Treatments to Patients Blog How Modeling and Simulation Can Bring New Immuno-oncology Treatments to Patients Immuno-oncology, which harnesses the patient's own immune system to fight cancer, is one of the…CertaraFebruary 16, 2016
Conventional & Mechanistic IVIVC: Complementary or Clashing Methods? Blog Conventional & Mechanistic IVIVC: Complementary or Clashing Methods? An IVIVC (in vitro-in vivo correlation) is a mathematical relationship that predicts key pharmacokinetic parameters…CertaraFebruary 9, 2016