The Anatomy of a Great Modeling and Simulation Project

In therapeutic areas with tough competition, it is challenging to establish a complete, confident understanding of a drug’s safety and efficacy profile. Any misunderstanding of a drug’s characteristics can derail the entire development program. Modeling and simulation, also known as model-based drug development, uses a number of techniques, such as population PK modeling, model-based meta-analysis, … Continued

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

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