Dictionary of pharmaceutical medicine

253 Pages·2009·0.834 MB·English

by  Gerhard Nahler, Annette Mollet

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.
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is concerned, specifically those of translation, reprinting, re-use
of illustrations, broadcasting, reproduction by photo copying
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
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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 com-
bined 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 ge-
nomic 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 un-
derstanding 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 disci-
plines and specialists need to be informed: they include physicians,
pharmacists, biologists, chemists, biostatisticians, data managers, in-
formation specialists, business developers, marketing experts as well
as regulators, financing specialists, healthcare providers and insur-
ers 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 be-
ginning, 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 applaud-
able. 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 dis-
cussion, 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 “sup-
ported” 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 pharmac ology
and drug therapy has over the last few years led to the creation of a
large number of new terms and their abbreviat ions 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.
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.
Univ.-Prof. Dr. Gerhart Hitzenberger
Österreichische Arbeitsgemeinschaft
für Klinische Pharmakologie
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 begin ning. Although post-graduate
formation is offered by an in creasing number of institutions, train-
ing in the field of pharma ceutical 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 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 growi ng. This makes it
difficult to keep such a dictionary “complete” and up-to-date. In addi-
tion, this dy namic process also leads to differences in an individual’s
understanding and utilisation of one and the same term. It will cer-
tainly occur that one person, also among readers, might interpret
or define some terms differently from another. I beg therefore the
user’s indulgence of these aspects and invite their comments.
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 800 frequently used abbrevia tions 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.
This dictionary is aimed primarily at the beginner entering this
discipline or coming into occasional contact with pharma ceutical
medicine as part of his/her daily work, as is the case with investi-
gators, researchers in the pharmaceutical industry, people in mar-
keting departments, drug regulatory affairs or governments. 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., Dr Bob Nolan and Dr Axel Wenzel in
the initial stages of this book. I should also like to thank for the per-
mission to reproduce some of the definitions and addresses cited
in this book.
Gerhard Nahler
Contents
Dictionary of pharmaceutical medicine ................................................1
Abbreviations/acronyms ...................................................................199
Selected bibliography .........................................................................228
Useful websites ...................................................................................239
1
abbreviated new drug application Application for marketing autho- acc
risation if a drug has already received approval under a previous
conventional NDA; important drug properties as e.g. toxicity and
safety have therefore already been documented.
Aberdeen drug coding system → see code.
abriged application EC: “the applicant shall not be required to pro-
vide the results of pharmacological and toxicological tests or the
results of clinical trials if he can demonstrate: (i) either that the
proprietary medicinal product is essentially similar to a product
authorized … and that the person responsible for the marketing of
the original product has consented to the … references contained
in the file being used … (ii) or by detailed references to published
scientific literature … (iii) or that the product is essentially similar
to a product which has been authorized within the Community …
for not less than 6 (10) years and is marketed in the Member State
for which the application is made …; … where the … product is in-
tended for a different therapeutic use from that of the other products
marketed or is to be administered by different routes or doses, the
results of appropriate pharmacological and toxicological tests and/
or clinical trials must be provided”; → see also hybrid procedure.
absolute bioavailability → see bioavailability.
absolute risk → see risk.
absorption Process by which a drug enters the body; enteral absorp-
tion is most readily with non-ionized lipid-soluble drugs (e.g. etha-
nol), weak acids with pKa >3 and weak bases with pKa <7.8 are also
very well absorbed; absorption in the stomach becomes critical,
if the drug has a very low solubility in water (< 5mg/ml) or a low
lipid/water partition coefficient, or if the disintegration-/dissolu-
tion time is low; → see adme, administration, disintegration
test, pKa, route of administration.
accelerated approval program syn. fast track procedure; approval
of therapies “that provide a meaningful therapeutic benefit for pa-
tients with serious illness” (FDA) will be accelerated; a similar pro-
cedure exist in t he EC; in this case, approval relies solely or in part
on surrogate endpoints for evidence of effectiveness; the average
duration for marketing authorisation in the US takes more than 20
months; in an accelerated approval program substances are clas-
sified according to their therapeutic potential in P (priority) and S
(standard) substances; → see approval, new drug application,
surrogate endpoint.
accelerated testing → see stress testing.
acceptable daily intake (ADI) Maximal amount of trace element,
mineral and other substances which can be taken lifelong without
any harm to health; → see also defined daily dose.