ICER’s Unsupported Drug Price Increase Report: An Analysis Blog ICER’s Unsupported Drug Price Increase Report: An Analysis We analyze the drug-price watchdog, ICER’s (Institute for Clinical and Economic Review) “Report on Unsupported…Ulrich Neumann2019 年 10 月 24 日
Introducing P21 Community 3.0 Announcement Introducing P21 Community 3.0 2019 年 5 月 7 日 We are thrilled to announce that P21 Community 3.0 is available for immediate…Simona Colucci2019 年 5 月 7 日
New Pinnacle 21 Enterprise 4.0 Eases Concern about PMDA Submissions Announcement New Pinnacle 21 Enterprise 4.0 Eases Concern about PMDA Submissions 2019 年 4 月 2 日 Released March 31, the new P21 Enterprise 4.0 provides more options for…Simona Colucci2019 年 4 月 2 日
What’s New in Enterprise 3.4 Q&A Announcement What’s New in Enterprise 3.4 Q&A Is there documented guidance on the creation of the sponsor SDTM metadata to be uploaded…Simona Colucci2018 年 5 月 17 日
Abundance of Hepatic Transporters in Caucasians: A Meta-analysis Publication Abundance of Hepatic Transporters in Caucasians: A Meta-analysis The aim of this study was to derive quantitative abundance values for key hepatic transporters…webdev2016 年 10 月 1 日
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…webdev2016 年 7 月 1 日
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…webdev2016 年 6 月 1 日
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 webdev2016 年 6 月 1 日
Reference-scaled Average Bioequivalence Blog 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 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…webdev2016 年 4 月 1 日