Drug Discovery and Evaluation: Methods in Clinical Pharmacology

Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined.

As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".

For the 2^nd edition, all the existing chapters have been revised and completely updated. A large number of assays were added. New chapters were included, such as pain, addiction, gene therapy, orphan diseases etc. etc. The complete work was new arranged.

Since retiring from Aventis in 2002, Dr. Franz Jakob Hock has leveraged his experience as a freelance consultant specializing in Safety Pharmacology. Dr. Hock was a research scientist at Hoechst, Hoechst Marion Roussel and Aventis from 1976 – 2002. He lectured for several years at the University of Kassel und the Technical University of Darmstadt. Currently he is a member of the Task Force General/Safety Pharmacology German/Swiss Pharmaceutical Companies and a member of the Program Committee of the Safety Pharmacology Society.

Michael R. Gralinski, Ph.D. Chief Executive Officer, Co-Founder (CorDynamics). Mike is the Chief Executive Officer and Co-Founder of CorDynamics, a cardiovascular contract research organization and consulting group in Chicago. Along with his partners, Mike started CorDynamics in 2003 and since then the company has grown into a leading provider of nonclinical cardiovascular services for more than 300 international biopharmaceutical clients. Mike also has extensive management experience working for several pharmaceutical organizations including Warner-Lambert/Parke-Davis, G.D. Searle, Monsanto, Pharmacia, and Pfizer. His past responsibilities included directing product safety and toxicology operations, leading resolution efforts for cardiovascular issues involving discovery, development, and marketed compounds including Rezulin, Celebrex, and other COX-2 inhibitors, as well as cultivating relationships with international colleagues throughout small and large biopharma. He was involved in the genesis of the Safety Pharmacology Society and has been elected to multiple positions on its Board of Directors including Treasurer, Vice-President, and President. Mike earned his B.S. in Pharmacology & Toxicology at the University of Wisconsin-Madison and Ph.D. in Pharmacology at the University of Michigan.