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".

As with the earlier books, this volume will be of interest to a broad range of people involved in drug research, chemists, pharmacists, pharmacologists, research institutes in academia and industry, registration authorities, but in peculiar to every physician testing and using drugs. The intention is to have a kind of 'recipe-book' in the respective areas, therefore the different chapters have a quite similar predefined structure. The characteristics in clinical pharmacology are of interest not only to the specialist but also to all physicians working in general practice.

Franz J. Hock Since retiring from Aventis in 2002, Dr. 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 to 2002. He initially worked on methods in general pharmacology and nephrology, before becoming Head of Laboratory and devoting to pharmacological methods for drugs influencing memory and learning. He was ultimately Head of Laboratory for General/Safety Pharmacology at the Frankfurt site of Aventis Pharma Deutschland GmbH. Dr. Hock received his M.Sc. in Neurobiology from the Technical University Darmstadt and his D.Sc. in Zoology from the University Kassel, Department of Biology, Institute of Neuroethology and Biocybernetics. He received the degree of Fachpharmakologe DGPT ("Certified Expert Pharmacology") in 1981. In 1983, Dr. Hock spent a sabbatical year at the University of California, Irvine, at the Center for the Neurobiology of Learning and Memory (Director Prof. Dr. James L. McGaugh). He lectured for several years to student of Biology at the University of Kassel and the Technical University Darmstadt. He has published over 100 original papers on methods in pharmacology and on new compounds. Furthermore, he held 28 patent applications to protect or broaden the application of lead structures. He is currently a member of the Task Force General/Safety Pharmacology German/Swiss Pharmaceutical Companies and is also member of several national and international scientific societies. Dr. Hock is founding member of "Safety Pharmacology Society," "Neurowissenschaftliche Gesellschaft e.V.," and "European Behavioural Pharmacology Society." For several years, he is serving as a member of the Program Committee of the Safety Pharmacology Society. Dr. Hock is member of several domestic and international scientific societies.

Michael R. Gralinski is an internationally recognized authority and advisor in cardiovascular pharmacology. He has founded multiple contract research and consulting companies and is currently the Chief Executive Officer of CorDynamics, a position he has held since 2002. He has more than 25 years of experience in pharmaceutical research and development with deep expertise in cardiovascular pharmacology and toxicology experimental design, data analysis, and interpretation.

Prior to CorDynamics, Dr. Gralinski garnered extensive management experience working for several pharmaceutical organizations including WarnerLambert/Parke-Davis, G.D. Searle, Pharmacia, and Pfizer. His past responsibilities included directing product safety and toxicology operations, leading resolution efforts for cardiovascular issues involving discovery and 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 was elected to multiple positions on its Board of Directors including Treasurer, Vice-President, and President. Dr. Gralinski earned a Bachelor of Science degree in Pharmacology and Toxicology from the University of Wisconsin-Madison and a Doctor of Philosophy in Cardiovascular Pharmacology from the University of Michigan.