As a trained pharmacist and scientist, I think a lot about patient care and how the drug development process impacts drug labels and the clinical use of medicines. Modeling and simulation technology encompasses methods such as physiologically based pharmacokinetic (PBPK) models. PBPK provides insight into drug mechanisms. It also helps clinicians provide the safest and … Continued
PRINCETON, NJ – Sept. 25, 2015 –Certara®, the global biosimulation technology-enabled drug development company, today announced that it partnered with the Critical Path to TB Drug Regimens (CPTR) to develop a tuberculosis (TB) biomarker in Phase II which was predictive of durable cure in Phase III. Their meta-analysis was presented at the 8th International Workshop … Continued
Over the course of my career, I have taught the theory and practical applications of PK/PD modeling to hundreds of scientists. In this blog post, I’ll share some of my most popular tips for solving common difficulties encountered by pharmacometricians. The tools of the trade While I have worked with a number of pharmacometrics tools, I … Continued
PRINCETON, NJ and DURHAM, NC – Sept. 10, 2015 – Certara®, the global biosimulation technology-enabled drug development company, and Paidion Research, Inc., a pediatric clinical research organization (CRO), today announced a new partnership dedicated to promoting more efficient and reliable drug development for pediatric patients. The partnership harnesses Certara’s unmatched biosimulation (modeling and simulation) and … Continued
Physiologically based pharmacokinetic (PBPK) models can over-predict maximum plasma concentrations (Cmax) following intravenous administration. A proposed explanation is that invariably PBPK models report the concentration in the central venous compartment, rather than the site where the samples are drawn. The purpose of this study was to identify and validate potential corrective models based on anatomy and physiology governing the blood supply at the site of sampling and incorporate them into a PBPK platform. Four models were … Continued
The published OS model and resultant simulations can be leveraged to support Phase II design and predict expected OS and HR (based on early observed TGI data obtained in Phase II or Phase III studies), thereby informing important mRCC development decisions, e.g., Go/No Go and dose regimen selection.
