Skip to main content

AAPS Selects Certara Vice President of Research and Development Professor Amin Rostami as a Fellow

Honor recognizes his advances in predicting in vivo drug responses based on in vitro data ST. LOUIS, MO – Feb. 26, 2014 – Certara™, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, today announced that Amin Rostami, Pharm.D., Ph.D., FCP, the company’s vice … Continued

Extrapolating AUC to Infinity

Area under the curve or AUC is a pharmacokinetic statistic used to describe the total exposure to a drug. More specifically, it is the time-averaged concentration of drug circulating in the body fluid analyzed (normally plasma, blood or serum). Standard calculation of AUC involves using non-compartmental techniques to calculate the AUC from time 0 to … Continued

Certara Conducts Model-based Meta-analysis to Compare Efficacy, Tolerability of Two Pain Medications

Data published in Pain and Therapy compare tramadol with tapentadol ST. LOUIS, MO – Feb. 24, 2014 – Certara™, a leading provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, announced today that its model-based meta-analysis comparing tramadol with tapentadol for the treatment of chronic nonmalignant … Continued

Population Pharmacokinetic Analysis of Axitinib in Healthy Volunteers

Axitinib is a potent and selective second generation inhibitor of vascular endothelial growth factor receptors 1, 2 and 3 approved for second line treatment of advanced renal cell carcinoma. The objectives of this analysis were to assess plasma pharmacokinetics and identify covariates that may explain variability in axitinib disposition following single dose administration in healthy … Continued

Managing Pre-clinical Study Data as a Strategic Asset

In this webinar, David Lowis, D. Phil. of Certara, makes the case for adopting a solution that allows immediate access, visualization and analysis of pre-clinical data for optimized decision making, while leveraging the FDA mandated CDISC-SEND data standard. Joining Dr. Lowis will be Stuart Horowitz, PhD, President of Institutional Services at WIRB-Copernicus Group. Dr. Horowitz … Continued

Hyperlinking: Making the Most of Navigation in eCTD Submissions

When authors generate documents intended for electronic submission they use blue-colored font to indicate where a hyperlink should be added to allow the reviewer to easily access the cross-referenced information. Hyperlinks guide the reviewer closer to the source data or supportive information cited in the body of a document. There are a few industry standards … Continued

1 of 1