Pinnacle 21 Wins TOPRA Award for Regulatory Excellence in Innovation Announcement Pinnacle 21 Wins TOPRA Award for Regulatory Excellence in Innovation Certara’s Pinnacle 21 is honored to announce that Max Kanevsky, has been named to the…CertaraDecember 1, 2016
How to Prepare a Study Data Standardization Plan (SDSP) for FDA Blog How to Prepare a Study Data Standardization Plan (SDSP) for FDA Get up-to-speed on Study Data Standardization Plan (SDSP) for FDA submissions. Read the blog post…CertaraJuly 25, 2016
More Power to OATP1B1: An Evaluation of Sample Size in Pharmacogenetic Studies Using a Rosuvastatin PBPK Model for Intestinal, Hepatic, and Renal Transporter-mediated Clearances Publication More Power to OATP1B1: An Evaluation of Sample Size in Pharmacogenetic Studies Using a Rosuvastatin PBPK Model for Intestinal, Hepatic, and Renal Transporter-mediated Clearances Rosuvastatin is a substrate of choice in clinical studies of organic anion-transporting polypeptide (OATP)1B1- and…CertaraJuly 1, 2016
Development of a Permeability-limited Model of the Human Brain and Cerebrospinal Fluid (CSF) to Integrate Known Physiological and Biological Knowledge: Estimating Time Varying CSF Drug Concentrations and Their Variability Using In Vitro Data Publication Development of a Permeability-limited Model of the Human Brain and Cerebrospinal Fluid (CSF) to Integrate Known Physiological and Biological Knowledge: Estimating Time Varying CSF Drug Concentrations and Their Variability Using In Vitro Data A 4-compartment permeability-limited brain (4Brain) model consisting of brain blood, brain mass, cranial and spinal…CertaraJune 1, 2016
Metformin and Cimetidine: Physiologically-based Pharmacokinetic Modeling to Investigate Transporter Mediated Drug–drug Interactions Publication Metformin and Cimetidine: Physiologically-based Pharmacokinetic Modeling to Investigate Transporter Mediated Drug–drug Interactions CertaraJune 1, 2016
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…CertaraApril 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
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
Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko Blog 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…CertaraDecember 1, 2015