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".

"We pharmacologists must acquire a knowledge of the tools we use . . . Fortunately a surgeon who uses the wrong side of a scalpel cuts his own fingers and not the patient; if the same applied to drugs they would have been investigated very carefully a long time ago . . . More ceterum censeo is perhaps necessary in order to rouse pharmacology from its sleep. The sleep is not a natural one since pharma­ cology, as judged by its past accomplishments, has no reason for being tired. " From R. Buchheim Beiträge zur Arzneimittel/ehre, Voss, Leipzig, 1849. Chapter 1 Preface and introduction Methods, clinical pharrnacology and the clinical pharmacologist In this book are brought together the proceedings from lecures and poster-demonstrations at the International Symposium on Methods in Clinical Pharmacology held in Frankfurt, May 6th-8th 1979. The symposium provided a forum for a group of invited clinical pharmacologist to speak on a topic of their own selection. They were asked to place special emphasis on the methodological aspects of their work they considered to be important. Seventeen of the speakers came from overseas. The sym­ posium was thus an attempt to establish a methodological basis for further advancements in clinical pharmacology. This book, we hope, will be recognised as documentary evidence that this has been done. Owing to the considerable advancements that have been achieved, it may be forgotten or not realised that clinical pharmacology is a relativelyyoung discipline (7 to 10 years at the most).

Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials. This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials. Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.

Atkinson’s Principles of Clinical Pharmacology, Fourth Edition is the essential reference on the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This well-regarded survey continues to focus on the basics of clinical pharmacology for the development, evaluation and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the fourth edition has been thoroughly updated to provide readers with an ideal reference on the wide range of important topics impacting clinical pharmacology. Presents the essential knowledge for effective practice of clinical pharmacology Includes a new chapter and extended discussion on the role of personalized and precision medicine in clinical pharmacology Offers an extensive regulatory section that addresses US and international issues and guidelines Provides extended coverage of earlier chapters on transporters, pharmacogenetics and biomarkers, along with further discussion on "Phase 0" studies (microdosing) and PBPK

Screening Methods in Pharmacology, Volume II is a collection of papers that presents practical techniques and information on the selection of a screening program for a particular pharmacological activity. The book contains the most reliable, simplest, and the most preferred screening methods in pharmacology. The text presents screening methods for alpha and beta Adrenergic blocking agents; compounds for antianginal activity; topical products for excessive eccrine sweating; antidepressant agents; and agents with analgesic and analgesic antagonist activity. Pharmacologists, pharmacists, researchers, and physicians will find this book a good source of information.