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? Therefore Dr. 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. 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. 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 knowl- edge introduced by specialists in widely differing fields.
As a result of the expansion in the area of pharmaceutical medicine there is an ever-increasing need for educational resources. The Dictionary of Clinical Trials, . Dictionary for Clinical Trials 2nd Edition. by . The Dictionary of Clinical Trials, Second Edition comprehensively explains the words and short phrases.
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 con- tinuously 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. Preface of the 1st edition Pharmaceutical medicine nowadays is a multidisciplinary area com- prising aspects of toxicology, pharmacology, statistics, drug-regula- tory 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.
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 keywords, the attention of the user is drawn to such rela- tionships by cross-references printed in small capitals.
In addition, it is always a difficult decision as to whether to in- clude 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 fur- ther information and not only with a compilation of citations. As a consequence, some important documents are listed in the back mat- ter 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 pharmaceuti- cal medicine is in permanent evolution and growing. It will cer- tainly occur that one person, also among readers, might interpret or define some terms differently from another. A further important aspect is the utilisation of abbreviations. Technical jargon usually tends to create its own abbreviations, and this is also true for the field of pharmaceutical medicine. A separate register of more than frequently used abbreviations is therefore included.
IX Preface of the 1st edition Finally a directory of important national and international bod- ies and organisations as well as authorities completes the back mat- ter.
This may help to establish contacts and to get further informa- tion. I hope however that the content will also be of interest to experienced col- leagues in departments engaged in clinical development. As everybody knows, it is impossible to write such a dictionary with- out the helpful criticism of experienced colleagues and friends. I wish therefore to acknowledge many of comments and useful dis- cussions with Dr Dominique B. I should also like to thank for the per- mission to reproduce some of the definitions and addresses cited in this book.
Gerhard Nahler 8.
Contents Dictionary of pharmaceutical medicine ADME abbr. Japan recommend to document a sufficient number of subjects to detect ADRs with an incidence of 0. ATC exemption scheme Scheme similar to the clinical trial ex- emption scheme for animal health products.
Uniform requirements for manuscripts submitted to biomedical journals. N Engl J Med , — Bayesian adverse reaction diagnostic instrument BARDI Bayes- ian based approach for assessing drug-induced illness; the goal is Production may be carried out by using intact organisms, such as yeasts and bacteria, or by using natural substances e.
US, France a c. Lead Ethics Committee; ethics com- mittee reviewing a protocol for different institutions, e. France, approval by one central e.
FDA may request studies with the racemate as well as with the isomers; however there exist also ex- amples where the racemate has synergistic properties e. CIOMS International, non-governmental, non-profit organisation, which was set up in under the auspices of the WHO and UNESCO; its prime functions include acting as sound board for capturing and disseminating informed opinion on new develop- ments in biology and medicine, and to explore their social, ethical, moral, administrative, and legal implications.
CIOMS I form Reporting form for adverse reactions; as a minimum they should contain the following information: identifiable source, patient identification, a suspect drug, a suspect reaction; manu- facturers should submit completed CIOMS council for inter- national organisation of medical sciences report forms to regulatory authorities as soon as they are received but not later than 15 working days after their receipt; this period begins as soon as a company, or any part or affiliate of a company, receives the report; many regulatory authorities including of Eastern Europe accept this format for reporting, e.
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