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Quantitative Pharmacology Strategies for Pediatric Drug Development

Pediatric patients are not simply small adults. Children differ from adults in both disease pathophysiology and pharmacokinetics/pharmacodynamics (PK/PD). Yet historically, 80 percent of medicines used in children had little to no data guiding prescribers on proper use. In this blog post, I’ll discuss the challenges of developing drugs for children and explain how quantitative pharmacology … Continued

FDA’s New Module 1 is a Bridge to eCTD 4

Editor’s note: Jason Rock served as Project Lead for the HL7 RCRIM Expert Working Group that developed the Regulated Product Submissions (RPS) standard. This post is the third in a series on the Next Major Version (NMV) of eCTD, eCTD 4, which is based on the RPS standard. The evolution of the Electronic Common Technical … Continued

Arming Adherence-based Drug Development with Pharmacometrics

The time is right to explore how sensor-enabled digital adherence monitoring systems can benefit patients, sponsors, and payers. Non-adherence to prescribed medications is a key issue facing our healthcare industry, costing the US healthcare economy between $100-300 billion annually, representing between 3-10% of total healthcare costs.1,2 Further, non-adherence also decreases our ability to capture dose-response … Continued

Phoenix NLME, The Modern PK/PD Modeling Software for Today’s Scientists

Phoenix NLME is the PK/PD modeling software that is user-friendly and easy-to-learn. Built from the ground up on the Phoenix workbench architecture, Phoenix NLME enables users to focus on modeling, and not on the tools or coding required to implement the modeling. The result is more time for analysis and strategic decision-making.

D360 Express Scientific Data Informatics Hub

D360 Express is an out-of-the-box integrated solution specifically designed for discovery scientists at smaller pharmaceutical research organizations. It provides access, integration, analysis and visualization of scientific data from multiple data sources. D360 Express gets you up and running quickly and affordably.

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