Reference-scaled Average Bioequivalence
The standard approach for approval of generic drugs is to run a bioequivalence study to…
Certara2016 年 5 月 12 日
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…
Danielle Pillsbury2016 年 4 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
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
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
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
Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko
Pharmacometrics uses mathematical models of biology, pharmacology, disease, and physiology to describe and quantify interactions…
Certara2015 年 12 月 1 日
Interplay of Metabolism and Transport in Determining Oral Drug Absorption and Gut Wall Metabolism: A Simulation Assessment Using the “Advanced Dissolution, Absorption, Metabolism (ADAM)” Model
Bioavailability of orally administered drugs can be influenced by a number of factors including release…
Danielle Pillsbury2015 年 11 月 1 日
Introducing OpenCDISC Enterprise 3.0
Pinnacle 21 is proud to announce the launch of OpenCDISC Enterprise 3.0, which will be…
Certara2015 年 10 月 27 日
Max Kanevsky named to the PharmaVOICE 100 List of the Most Inspiring People
Certara’s Pinnacle 21 is honored to announce that Max Kanevsky, has been named to the…
Certara2015 年 8 月 5 日
Common Misconceptions About Computer System Validation
Drug development professionals frequently use computer systems to help them understand the pharmacokinetics (PK) and…
Certara2015 年 1 月 28 日
