Drug development can be a lengthy and costly process and many new drug candidates fail during clinical trials. Many new drugs present a mixed picture of efficacy and toxicity, making development decisions difficult. Population PK/PD analysis allows for more efficient use of clinical trial results for decision making in several ways: 1) it can provide better insights as to how patients tolerate and respond to a new drug; 2) it can shorten development time via the conduct of informative trials; and 3) it can help identify drug candidates that are unlikely to meet target clinical therapeutic goals early in development. The use of these methods allows more rapid identification of appropriate dose regimens so fewer clinical trials are needed. The ability to make timely and well informed development decisions translates to major cost savings.
Projections Research, Inc. uses population pharmacokinetic (PK) and pharmacodynamic (PD) models to describe the time course of individual patient exposure and response to a new treatment. PK is the study of how the body processes a drug and PD is the study of how the drug acts on the body. Population PK/PD models are used to determine how patient factors such as demographics, disease status and progression, and co-medications, might affect patient exposure to drug and their subsequent response. The models can be used to simulate different dose regimens and treatment options. The simulation results can then help design more informative and robust clinical studies.
Projections Research, Inc. is a scientific consulting firm that provides expertise in clinical pharmacology to the pharmaceutical industry. The company utilizes a unique corporate structure and a team composed of highly skilled scientists from around the world. The company makes use of innovative modeling and simulation applications to advance client understanding of both new and marketed drugs and the diseases these drugs are used to treat. The Projections Research, Inc. client list includes most of the major pharmaceutical and many smaller companies.