Motesanib’s Promise & Peril: Population PK Modeling an Anticancer Drug

Nathalie Gosselin

When thinking about the challenges of oncology drug development, I recall the advice of the 6th century BCE military strategist, Sun Tzu: If you know the enemy and know yourself, you need not fear the result of a hundred battles. If you know yourself, but not the enemy, for every victory gained you will also […]

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Topics: PK/PD Modeling & Simulation

Pediatric Drug Dosing: Tackling Big Problems for Little Patients

Nastya Kassir

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 […]

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Topics: PK/PD Modeling & Simulation

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

Ana Henry

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 […]

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Topics: PK/PD Modeling & Simulation
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