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Gerhard Nahler Dictionary of Pharmaceutical Medicine second revised and enlarged edition With contribution by Annette Mollet SpringerWienNewYork Dr. med. Dr. phil. Gerhard Nahler Clinical Investigation Support Pharmaforschung Vienna, Austria With contribution by Dr. Annette Mollet European Center of Pharmaceutical Medicine This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concerned, specifically those of translation, reprinting, re-use of illustrations, broadcasting, reproduction by photocopying machines or similar means, and storage in data banks. Product Liability: The publisher can give no guarantee for all the information contained in this book. This does also refer to information about drug dosage and application thereof. In every individual case the respective user must check its accuracy by consulting other pharmaceutical literature. The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. © 2009 Springer-Verlag/Wien Printed in Germany SpringerWienNewYork is a part of Springer Science + Business Media springer.at Coverphoto: Andrzej Tokarski/istockphoto Typesetting: Composition & Design Services, Minsk 220027, Belarus Printing: Strauss GmbH, 69509 Mörlenbach, Germany Printed on acid-free and chlorine-free bleached paper SPIN: *** Library of Congress Control Number: ***76 ISBN 978-3-211-89835-2 SpringerWienNewYork ISBN 3-211-82557-6 1. Edition SpringerWienNewYork Foreword In the beginning was the word – and the foreword. Words are combined to sentences and eventually language. Words are listed in a dictionary and their meaning in building language are explained in a lexicon. In the life sciences – e.g. drug development sciences and pharmaceutical medicine – the analogies are evidenced by the genomic library and patho-physiological function as the lexicon. In this transition from code to function integrated lexica pay a pivotal role for a faster understanding. The present updated version of this books combines dictionary and lexicon and provides the translational understanding of the complex drug development process. With a large number of new terms, their abbreviations and explanations in this complex interdisciplinary process a great number of different disciplines and specialists need to be informed: they include physicians, pharmacists, biologists, chemists, biostatisticians, data managers, information specialists, business developers, marketing experts as well as regulators, financing specialists, healthcare providers and insurers in a continuous professional development mode. This lexicon is therefore a most suitable and economical tool for fast and conclusive information for all key-players in the development of medicines at the working place, in postgraduate training as well as during graduate education. This book is an indispensible aid in any medical library. Prof. Dr. med. Dr. h.c. Fritz R. Bühler Director, European Center of Pharmaceutical Medicine, ECPM at the Medical Faculty and the PharmaCenter, University of Basel Co-ordinator, Pharmaceutical Medicine Training Programme of the Innovative Medicines Initiative, IMI, Joint Undertaking of EC and EFPIA Preface The Gospel according to St. John declares that the word was in the beginning, and that the word was with God. Our book here is no bible, but it tries to fight the Babylonian disarray of language. Have we not observed new English or German terms coming into use, with almost as many connotations that the famous CRA (Clinical research Associate) has had? Have we not seen IRB literally translated into something like “Institutionelles Aufsichtsgremium” or worse? Therefore Dr. Nahler’s renewed attempt to collect and associate all those terms, abbreviations, and acronyms is more than applaudable. Too many discussions are held leading to controversies just in the absence of a reliable lexicon which also shows the ambiguity of words which we use as if everybody should understand them the same way. While is will be hard to use the dictionary in a live discussion, its prolonged use may sensitise many to those issues, and it is hoped that in books on the subject the use of terms will be “supported” by Dr. Nahler’s attempt to better define them. I wish this book a broad use, including those that may browse through it having many “aha!” experiences. And, I am sure, due to its quality and the many changes in our profession, in a few years we shall have a new edition of it equally thorough and good to read. Michael Herschel, M.D., Ph.D., MBA, FFPM Director Clinical research GlaxoSmithKline GmbH&Co. KG Foreword of the 1st edition The evolution of pharmaceutical medicine, clinical pharmacology and drug therapy has over the last few years led to the creation of a large number of new terms and their abbreviations with the result that physicians and pharmacists are at a loss when confronted with these terms. This is also due to the fact that everything connected with pharmaceutical medicine is based on interdisciplinary knowledge introduced by specialists in widely differing fields. The present book is most welcome, as it gives short and precise information on nearly all questions. Statistics, clinical pharmacology with its different branches, issues of clinical drug investigation and pharmacotherapy as such are dealt with. Definitions of individual terms reflect, of course, the present state and will need to be continuously updated as to their meaning. This book is therefore most suitable for students of pharmacy and medicine as well as pharmacists and physicians as a source of quick and conclusive information. I therefore hope that this publication will meet with success and widespread approval. Univ.-Prof. Dr. Gerhart Hitzenberger Österreichische Arbeitsgemeinschaft für Klinische Pharmakologie Preface of the 1st edition Pharmaceutical medicine nowadays is a multidisciplinary area comprising aspects of toxicology, pharmacology, statistics, drug-regulatory and legal affairs, medicine and a number of other disciplines. Therefore it is necessary to acquire additional knowledge to whatever one has studied or done at the beginning. Although post-graduate formation is offered by an increasing number of institutions, training in the field of pharmaceutical medicine is largely “on the job” and done mainly by the pharmaceutical industry or contract research organisations. Many years of experience with new colleagues showed me how useful some sort of booklet might be, that would give them a better understanding of some of the less familiar technical terms and their context. In this dictionary, containing at present more than 800 keywords, the attention of the user is drawn to such relationships by cross-references printed in small capitals. In addition, it is always a difficult decision as to whether to include citations or not and there was a great temptation to make references throughout the text to important publications especially those of health authorities. However, this would certainly have been beyond the scope of a brief dictionary intended for daily use and I find it absolutely necessary that the user familiarises him- or herself with original, complete texts and specific, original literature for further information and not only with a compilation of citations. As a consequence, some important documents are listed in the back matter of this book. It was after all these deliberations that the idea of producing this particular type of short dictionary in its present form was born. As is the problem with almost all dictionaries, information given therein must be short. Furthermore, the discipline of pharmaceutical medicine is in permanent evolution and growing. This makes it difficult to keep such a dictionary “complete” and up-to-date. In add 内容过长，仅展示头部和尾部部分文字预览，全文请查看图片预览。 lations http://doc.001pp.com/CFR/ European Clinical Trials Directive Directive 2001/20/EC http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/dir 200120ec.htm – Declaration of Helsinki http://doc.001pp.com/e/policy/b3.htm – Common Toxicity Criteria http://ctep.cancer.gov/reporting/ctc.htm – Drug Development and Drug Interactions http://ctep.cancer.gov/reporting/ctc.html – Common Technical Document http://doc.001pp.com/cache/compo/1325-272-1.html – http://doc.001pp.com/cber/gollns/m4ctd.pdf [文章尾部最后500字内容到此结束,中间部分内容请查看底下的图片预览]请点击下方选择您需要的文档下载。

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