PK/PD Modeling And Simulation Optimization Tools

Quintiles has a wealth of experience in population PK/PD modeling and simulation. Over the past 10 years, our team of scientists has worked on over 60 population PK/PD modeling projects involving 45 compounds across 13 different therapeutic areas, resulting in 20 NDA submissions.

A paper published by the FDA revealed that of 31 New Drug Applications (NDAs) submitted over a 15-month period, a pharmacometric component (i.e., population PK/PD modeling and simulation) was ranked as important in the decision-making process for over 85%.

Not only did 20 of the 31 NDAs gain FDA approval as a result of analysis of their population PK/PD modeling and simulation, but also decisions on labeling (both pivotal and supportive) were influenced in 17 of the 31 cases.

Of the reviews that shaped labeling decisions, 75% contributed to statements on dosage or administration, 53% to precautions or warnings and 70% to clinical pharmacology labeling.