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.