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…Danielle Pillsbury2016 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 Danielle Pillsbury2016 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…Danielle Pillsbury2016 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)…Danielle Pillsbury2016 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 Danielle Pillsbury2016 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
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…Danielle Pillsbury2016 年 2 月 18 日
How Modeling and Simulation Can Bring New Immuno-oncology Treatments to Patients Blog 建模与模拟如何为患者带来新型的免疫肿瘤疗法 Immuno-oncology, which harnesses the patient's own immune system to fight cancer, is one of the…Certara2016 年 2 月 16 日
Conventional & Mechanistic IVIVC: Complementary or Clashing Methods? 博客 Conventional & Mechanistic IVIVC: Complementary or Clashing Methods? An IVIVC (in vitro-in vivo correlation) is a mathematical relationship that predicts key pharmacokinetic parameters…Certara2016 年 2 月 9 日