Table Of Content

Gerhard Nahler Dictionary of Pharmaceutical Medicine Third Edition Dictionary of Pharmaceutical Medicine Gerhard Nahler Dictionary of Pharmaceutical Medicine Third Edition With contribution by Annette Mollet Gerhard Nahler Clinical Investigation Support Pharmaforschung GmbH Wien Austria ISBN 978-3-7091-1522-0 ISBN 978-3-7091-1523-7 (eBook) DOI 10.1007/978-3-7091-1523-7 Springer Wien Heidelberg New York Dordrecht London Library of Congress Control Number: 2013936441 © Springer-Verlag Wien 2013 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, speci fi cally the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on micro fi lms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. Exempted from this legal reservation are brief excerpts in connection with reviews or scholarly analysis or material supplied speci fi cally for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work. Duplication of this publication or parts thereof is permitted only under the provisions of the Copyright Law of the Publisher's location, in its current version, and permission for use must always be obtained from Springer. Permissions for use may be obtained through RightsLink at the Copyright Clearance Center. Violations are liable to prosecution under the respective Copyright Law. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a speci fi c statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. While the advice and information in this book are believed to be true and accurate at the date of publication, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com) 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 com- bines 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, fi nancing 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 v Preface Over the last few years pharmaceutical medicine has evolved with a speed never seen before. Pharmaceutical medicine comprises clinical pharmacology, molecular biology, pharmacotherapy, toxicology, pharmacovigilance, epidemi- ology, chemistry, drug manufacturing, regulatory and legal affairs, marketing, statistics, data management, and a number of additional areas such as health care and insurance. Even alimentation is important for the effects of medica- tions if one considers the possibility of interactions as an example. The ongoing evolution of above mentioned areas has resulted in a rapid increase of new guidelines issued by health authorities as well as in adaptations of those that already exist. As an example, the European Community Directive 2001/83/EC, relating to medicinal products for human use, has been amended nine times between 2001 and 2011, by Dir 2002/98, Dir 2003/63, 2004/24, 2004/27, Dir 2008/29, 2009/53, 2009/120, 2010/84, 2011/62. Efforts were made in this book to scope with these changes. I beg for the user’s indulgence if anything has been omitted that would have been useful in the eyes of the user. It is absolutely necessary that the user familiarises him- or her with the original, most actual texts for further information. This ongoing evolution has also led in some cases to a slight change in our understanding and common use of terms, e.g. “study” versus “trial”, both of which are often used synonymously, but also to the creation of new terms and their abbreviations with the result that some might be faced with a Babylonian disarray of language. More than once one person may interpret and understand the same term in a different way from another. Hopefully this book contributes in reducing such ambiguities. Where “true” synonyms exist such as e.g., “mon- itor’s visit log list / site visit log / monitoring log list / appointment log” they are included in the text in order to make clear that these terms mean the same. This dictionary gives short explanations to about 2,000 terms, in addition to over 600 commonly used acronyms. The book is not an exhaustive presentation of all areas of pharmaceutical medicine but intends to be a “fi rst aide” in the vii viii Preface understanding of these terms on one hand as well as in their context on the other. For that, such relationships are highlighted by cross-references in small capitals. Where it might be useful, links to websites of institutions are included. Finally, important documents and science oriented websites are listed in the back matter of this book where the user can fi nd further information. This part includes also a directory of important national and international bodies, authorities and societies with their websites. This will facilitate to establish contacts and to get further help. Gerhard Nahler Contents Dictionary of Pharmaceutical Medicine A ............................................................................................................ 1 B ............................................................................................................ 19 C ............................................................................................................ 29 D ............................................................................................................ 60 E ............................................................................................................ 80 F ............................................................................................................ 97 G ............................................................................................................ 103 H ............................................................................................................ 111 I ............................................................................................................ 117 J ............................................................................................................ 134 K ............................................................................................................ 135 L ............................................................................................................ 137 M ............................................................................................................ 143 N ............................................................................................................ 156 O ............................................................................................................ 165 P ............................................................................................................ 171 Q ............................................................................................................ 202 R ............................................................................................................ 206 S ............................................................................................................ 222 T ............................................................................................................ 242 U ............................................................................................................ 250 V ............................................................................................................ 252 W ............................................................................................................ 256 X ............................................................................................................ 263 Y ............................................................................................................ 264 Z ............................................................................................................ 265 ix