Drug development continues to be time consuming, expensive, and inefficient, while pharmacotherapy is often practiced at a suboptimal level of performance. This trend has not waned despite the fact that vast amounts of data are obtained during clinical trials and patient care each year.

Within these data, knowledge that would improve drug development and pharmacotherapy lays hidden and undiscovered. With the publication of the Guidance for Industry: Population Pharmacokinetics by the Food and Drug Administration (FDA), and recently the FDA Critical Path Initiative: The Critical Path to New Medical Products, the assimilation of pharmacometrics as an applied science in drug development and evaluation is increasing.

Pharmacometrics is the science of quantitative clinical pharmacology that impacts decision making throughout the drug development and regulatory review process. It is based primarily on pharmacokinetic and pharmacodynamic modeling and simulation with applications including, among others, clinical trial design and dose optimization. Through the channel of quantitative drug, disease, and trial models, pharmacometric methods have the unique ability to leverage all prior and current information from diverse sources, including pathophysiology, clinical pharmacology, and statistics.

Our Pharmacometrics staff is a multidisciplinary team consisting of quantitative clinical pharmacologists, statisticians, engineers, and data management experts who work closely with clinicians and statisticians.