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By Stephan Schmidt and Hartmut Derendorf

Stephan Schmidt-finalH.Derendorf-finalSome recently approved drugs have come to the market with astronomical price tags. Pharmaceutical companies argue that they need to recover the increased drug development cost in order to survive as businesses. However, this trend of ever-increasing cost is not sustainable in the long run and not realistic for patients in most countries around the globe.

Pharmacometrics has become an essential discipline in modern drug development to increase its efficiency and lower the cost by making better choices, including earlier no-go decisions. With the increased regulatory burden and high expectations from prescribers and patients, it is neither cost-efficient nor time-efficient to tackle all open questions experimentally. More and more decisions are based on appropriate modeling and simulation, which allows integration of all available knowledge in a quantitative and objective way.

The new book Applied Pharmacometrics provides an update on the current state of pharmacometrics in drug development and examines numerous examples from various classes of drugs where pharmacometrics is applied to drug development to make it more efficient. After an introduction of the basic and underlying pharmacokinetic and pharmacodynamic concepts of pharmacometrics in drug development, the book presents numerous specific applications as examples that utilized pharmacometrics with modeling and simulations over a variety of therapeutic areas. These chapters were contributed and written by leading scientists from academia, the pharmaceutical industry, and regulatory agencies. The examples illustrate how results from all phases of drug development can be utilized and integrated in a more timely and cost-effective process.

The process of applying pharmacometric decision tools during drug development can allow data-based objective decision making. At the same time, the process can identify redundant or unnecessary experiments as well as some costly clinical trials that can be avoided. In addition to cost savings from the expedited development of successful drug candidates, pharmacometrics has important economic impacts in drug product selection: Unsuccessful drug candidates can be identified early and discontinued, without expending efforts required for additional studies and allocating limited resources. Hence, pharmacometric modeling and simulation has become a powerful tool to bring new and better medications to the patient at a faster pace and with greater probability of success.

Stephan Schmidt is an assistant professor at the University of Florida’s Center for Pharmacometrics and Systems Pharmacology (CPSP) in Lake Nona (Orlando), Florida.
Hartmut Derendorf is Distinguished Professor, V. Ravi Chandran Professor of Pharmaceutical Sciences, and Chairman of the Department of Pharmaceutics at the University of Florida College of Pharmacy in Gainesville. He has served as president of the American College of Clinical Pharmacology (ACCP) and president of the International Society of Antiinfective Pharmacology (ISAP).