Introducing P21 Community 3.0
May 7, 2019 We are thrilled to announce that P21 Community 3.0 is available for immediate…
CertaraMay 7, 2019
New Pinnacle 21 Enterprise 4.0 Eases Concern about PMDA Submissions
April 2, 2019 Released March 31, the new P21 Enterprise 4.0 provides more options for…
CertaraApril 2, 2019
What’s New in Enterprise 3.4 Q&A
Is there documented guidance on the creation of the sponsor SDTM metadata to be uploaded…
CertaraMay 17, 2018
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
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
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
A 4-compartment permeability-limited brain (4Brain) model consisting of brain blood, brain mass, cranial and spinal…
CertaraJune 1, 2016
Reference-scaled Average Bioequivalence
The standard approach for approval of generic drugs is to run a bioequivalence study to…
CertaraMay 12, 2016
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
