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…
Certara2019 年 4 月 2 日
What’s New in Enterprise 3.4 Q&A
Is there documented guidance on the creation of the sponsor SDTM metadata to be uploaded…
Certara2018 年 5 月 17 日
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…
Certara2016 年 12 月 1 日
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…
Certara2016 年 7 月 25 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
Rosuvastatin is a substrate of choice in clinical studies of organic anion-transporting polypeptide (OATP)1B1- and…
Certara2016 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
A 4-compartment permeability-limited brain (4Brain) model consisting of brain blood, brain mass, cranial and spinal…
Certara2016 年 6 月 1 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…
Certara2016 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…
Certara2016 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)…
Certara2016 年 3 月 1 日
