Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

The third edition of ‘Drug Discovery and Evaluation’ presents an expanded and updated version of one of the classic reference handbooks on safety and pharmacokinetic assays. Each assay description is sufficiently outlined and equipped with outstanding literature references. This comprehensive handbook mainly addresses the needs of pharmacological institutes and research groups working in this area.

• Bioanalytical Assays
• Clinical Studies
• Safety Assays
• Safety Pharmacokinetics
• Safety Pharmacology
• Safety Toxicology

• CorDynamics, Dieburg, Germany

  Franz J. Hock

• Cytokinetics (United States), South San Francisco, USA

  Michael K. Pugsley

Franz Jakob Hock received his Ph.D. degree (Sc.D.) in Zoology at the Institute of Neuroethology and Biocybernetics at the University of Kassel, Germany. He joined the Department of Pharmacology of the pharmaceutical company Hoechst AG in 1976. He initially worked on methods in general pharmacology and nephrology, before becoming head of a laboratory devoted to pharmacological methods for drugs influencing memory and learning. He was then appointed Head of the Laboratory of General and Safety Pharmacology at the Frankfurt site of Aventis Pharma Deutschland GmbH. He received the degree of Fachpharmakologe DGPT (“certified expert pharmacology”) in 1981.

In 1983 he 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 students in 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. He is currently a member of the Task Force General/Safety Pharmacology German/Swiss Pharmaceutical Companies. He served several times as a member of the program committee of the Safety Pharmacology Society. He is a member of several domestic and international scientific societies. He now works as a consultant in pharmaceutical business development.

Michael K Pugsley is the Senior Director of Toxicology & Safety Pharmacology at Cytokinetics Inc., where he currently designs, manages, interprets, and reports the findings from all non-clinical IND- and NDA-enabling toxicology studies for therapeutic areas including Heart Failure and Amyotrophic Lateral Sclerosis (ALS). Additionally, he leads the in-house conduct of all non-GLP toxicology studies for several discovery biology programs. He also provides high-level expertise to project and program teams and senior management, including evaluation of study conclusions and the potential impact of study results on program and clinical/regulatory strategy. He is a subject matter expert in the discovery, development and safety characterization of both small molecules and biologics in Cardiovascular, Diabetes, Neurological and Immunological therapeutic areas. He also is involved in the preparation of all non-clinical documents for regulatory (US, EU, Japan, and China) agency interactions and submissions.

He received his doctorate in Pharmacology & Therapeutics from The University of British Columbia, Vancouver, B.C., Canada and was a postdoctoral fellow at The University of California, Irvine in the Department of Molecular Genetics & Microbiology. Dr. Pugsley is a Fellow (FBPhS) of the British Pharmacology Society and a Diplomat (DSP) and Past President of the Safety Pharmacology Society (SPS). Michael has been working in the Pharmaceutical Industry for 25 years and is the author of 155 publications including 134 peer-reviewed articles, 21 book chapters and 5 books. He is also a member of the American College of Toxicology, Society of Toxicology, American Heart Association and Heart Failure Society of America.