How to Optimize Your Drug Label Using Modeling and Simulation Technology

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

Certara Presents Tuberculosis Biomarker Meta-Analysis and Pediatric Antibiotic Model at ASM

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

Regulatory Writing Experts Can Make You a Lean, Mean Pharma Machine

Getting your body into shape has a lot in common with helping implement regulatory medical writing best practices at a biopharmaceutical organization. Specifically, there are a number of similarities between engaging a regulatory writing consultancy and hiring a physical trainer. Unlike “Hans and Franz” of Saturday Night Live fame, who just want to “Pump YOU … Continued

9 Things Your Boss Wishes You Knew About PK/PD Modeling

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

Certara and Paidion Research Form Partnership Focused on Improving Pediatric Drug Development

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

The Future is Now: How 3D Printing Could Deliver Personalized Medicine

“It will take a few minutes to upload the instructions for your prescription to the 3D printer. We will call you once your medication is ready to be picked up.”  While it seems like science fiction, your pharmacist may describe filling your prescription using this emerging technology sooner than you might think. In this blog … Continued