Pediatric Drug Dosing: Tackling Big Problems for Little Patients

The challenges and complexities of pediatric drug development are well recognized. Pharmacometric modeling and simulation (M&S) leverages prior knowledge to support pediatric drug dosing, trial design and regulatory writing for submissions. As the benefits of pharmacometrics for drug development and regulatory decision-making become increasingly well documented, the FDA has challenged the industry to more rigorously apply … Continued

Why Phoenix NLME is the Best in Class Solution for Pop PK/PD

Over the past 20 years, I have seen a number of significant changes in the pharmaceutical industry’s approach to the study of pharmacokinetics and pharmacodynamics (PK/PD). With the high risk and large expense associated with drug development, it is imperative to have the best PK/PD analytical tools to aid in understanding the safety/efficacy profile of … Continued

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