Hartmut Derendorf – författare

Over the past decade, significant progress has been made in the theory and applications of pharmacodynamics of antimicrobial agents. On the basis of pharmacokinetic-pharmacodynamic modeling concepts it has become possible to describe and predict the time course of antimicrobial effects under normal and pathophysiological conditions. The study of pharmacokinetic-pharmacodynamic relationships can be of considerable value in understanding drug action, defining optimal dosing regimens, and in making predictions under new or changing pre-clinical and clinical circumstances. Not surprisingly, pharmacokinetic-pharmacodynamic modeling concepts are increasingly applied in both basic and clinical research as well as in drug development.

The book will be designed as a reference on the application of pharmacokinetic-pharmacodynamic principles for the optimization of antimicrobial therapy, namely pharmacotherapy, and infectious diseases. The reader will be introduced to various aspects of the fundamentals of antimicrobial pharmacodynamics, the integration of pharmacokinetics with pharmacodynamics for all major classes of antibiotics, and the translation of in vitro and animal model data to basic research and clinical situations in humans.

This comprehensive volume provides an update on the current state of pharmacometrics in drug development. It consists of nineteen chapters all written by leading scientists from the pharmaceutical industry, regulatory agencies and academia. After an introduction of the basic pharmacokinetic and pharmacodynamic concepts of pharmacometrics in drug development, the book presents numerous examples of specific applications that utilize pharmacometrics with modeling and simulations over a variety of therapeutic areas, including pediatrics, diabetes, obesity, infections, psychiatrics, Alzheimer’s disease, and dermatology, among others. The examples illustrate how results from all phases of drug development can be integrated in a more timely and cost-effective process.

Applying pharmacometric decision tools during drug development can allow objective, data-based 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 saving by expedited development of successful drug candidates, pharmacometrics has an important economic impact 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.