Executive Overview

Projections Research is a consulting firm providing expertise in clinical pharmacology to the pharmaceutical industry. Population pharmacokinetics and pharmacodynamics is a method that evaluates a drug in the target population, usually with fewer samples than would be required in a traditional Phase I study. The process involves developing mathematical models describing the exposure and response time courses. Population pharmacokinetic analyses provides information that can support labeling claims and dose adjustments because disease, and other factors such as age, weight, and race can alter the behavior of a drug. These effects can be detected and quantified using population based approaches. Regulatory agencies are supportive of the use of population pharmacokinetics and pharmacodynamics to support labeling, to help select doses in new patient populations, as well as in other applications.

Population models support clinical trial simulation (Nonmem) for examining study designs and selecting dose regimens with the greatest likelihood of success more quickly and less expensively than conducting exploratory studies.

Models can also be applied to sample time selection criteria. D-optimal sampling algorithms based on a population model not only help select the fewest number of samples per patient required for useful pharmacokinetic and pharmacodynamic information, but can be used to determine the minimum number of patients required for this evaluation, thereby saving time and money!

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