Dictionary of Pharmaceutical Medicine

186 Pages·1994·3.787 MB·English

by  Dr. med. Dr. phil. Gerhard Nahler (auth.)

Gerhard Nahler
Dictionary
of Pharmaceutical Medicine
Foreword byGerhartHitzenberger
Springer-Verlag WienGmbH
Dr.med. Dr.phil. Gerhard Nahler
CISClinical InvestigationSupportPharmaforschung
Vienna,Austria
Thiswork issubjectto copyright.
Allrightsare reserved,whether the whole orpartofthemate
rial isconcerned, specifically those of translation,reprinting,
re-use of illustrations, broadcasting, reproduction by photo
copyingmachinesorsimilarmeans,andstorageindatabanks.
©1994Springer-VerlagWien
OriginallypublishedbySpringer-VerlaglWien in1994.
PrintedbyEugen Ketterl Gesellschaftm.b.H.,A-1180Wien
Printed on acid-freeandchlorine-freebleachedpaper
Product Liability: The publisher can give no guarantee for
information about drug dosage and application thereofcon
tainedin this book.In everyindividualcasetherespectiveuser
must check its accuracy by consulting other pharmaceutical
literature.
The use ofregistered names, trademarks, etc. in this publica
tion doesnotimply,even intheabsenceofaspecificstatement,
thatsuch namesare exemptfrom the relevantprotectivelaws
andregulationsand thereforefree for general use.
ISBN978-3-211-82557-0 ISBN978-3-7091-4016-1(eBook)
DOI 10.1007/978-3-7091-4016-1
Foreword
The evolution of pharmaceutical medicine, clinical pharma
cologyand drug therapyhasover the last fewyearsled to the
creation ofa large number ofnew termsand their abbrevia
tionswith the resultthatphysiciansandpharmacistsareataloss
when confrontedwith these terms.Thisisalso due to the fact
that everything connected with pharmaceutical medicine is
based on interdisciplinaryknowledgeintroduced byspecialists
in widelydifferingfields.
The present book is most welcome, as it gives short and
precise information on nearlyall questions. Statistics,clinical
pharmacologywithitsdifferentbranches,issuesofclinicaldrug
investigation and pharmacotherapy as such are dealt with.
Definitionsofindividual terms reflect, of course, the present
state and will need to be continuously updated as to their
meaning.
Thisbookisthereforemostsuitableforstudentsofpharmacy
and medicineaswellaspharmacistsandphysiciansasasource
ofquickandconclusiveinformation.Itherefore hopethatthis
publication willmeetwith successand widespread approval.
Univ.-Prof.Dr. Gerhart Hitzenberger
Osterreichische Arbeitsgemeinschaft
fur Klinische Pharmakologie
Preface
Pharmaceuticalmedicine nowadaysisa multidisciplinaryarea
comprising aspects of toxicology, pharmacology, statistics,
drug-regulatory and legal affairs, medicine and a number of
otherdisciplines.Thereforeitisnecessarytoacquireadditional
knowledge to whateverone hasstudied or done at the begin
ning. Although post-graduate formation is offered by an in
creasingnumberofinstitutions,traininginthefieldofpharma
ceuticalmedicineislargely"onthejob"anddonemainlybythe
pharmaceutical industry or contract research organisations.
Manyyearsofexperiencewith newcolleaguesshowedme how
usefulsome sortofbookletmight be, thatwouldgive 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 ofthe user is
drawntosuchrelationshipsbycross-referencesprintedinsmall
capitals.
In addition,it isalwaysa difficultdecision as to whether to
include citations or not and there wasa great temptation to
makereferencesthroughoutthetexttoimportantpublications
especially those of health authorities. However, this would
certainly have been beyond the scope of a brief dictionary
intendedfordailyuseandIfinditabsolutelynecessarythatthe
user familiarises him- or herselfwith original, complete texts
andspecific,originalliteratureforfurtherinformationandnot
only with a compilation ofcitations. Asa consequence, some
importantdocumentsarelistedinthe backmatterofthisbook.
Itwasafterall these deliberations that the ideaofproducing
this particulartype ofshortdictionary in itspresentform was
born.
Asis the problem with almostall dictionaries, information
given therein must be short. Furthermore, the discipline of
pharmaceuticalmedicineisin permanentevolutionandgrow
ing.Thismakesitdifficulttokeepsuchadictionary"complete"
andup-to-date. In addition, this dynamic processalso leads to
differencesin an individual'sunderstandingandutilisationof
oneandthesame term.Itwillcertainlyoccurthatoneperson,
also among readers, might interpret or define some terms
differentlyfromanother.Ibeg thereforetheuser'sindulgence
oftheseaspectsand invite their comments.
Preface VIII
Afurtherimportantaspectisthe utilisationofabbreviations.
Technicaljargonusually tendstocreateitsownabbreviations,
and this isalso true for the field ofpharmaceuticalmedicine.
Aseparateregisterofmorethan800frequentlyused abbrevia
tions istherefore included.
Finally a directoryofimportantnational and international
bodies and organisations aswellas authorities completes the
back matter. This may help to establish contacts and to get
further information.
Thisdictionaryisaimed primarilyat the beginnerentering
thisdisciplineorcomingintooccasionalcontactwith pharma
ceutical medicine as partofhis/her dailywork,asis the case
with investigators,researchersin the pharmaceuticalindustry,
people in marketing departments, drug regulatory affairs or
governments.I hope however that the contentwillalso be of
interesttoexperiencedcolleaguesin departmentsengagedin
clinicaldevelopment.
Aseverybodyknows,itisimpossibletowritesuch adictionary
without the helpful criticism ofexperienced colleagues and
friends. I wish therefore to acknowledge many ofcomments
and useful discussions with Dr Dominique B.,Dr Bob Nolan
and DrAxelWenzelin theinitialstages ofthis book.Ishould
also like to thankfor thepermission toreproducesomeofthe
definitionsandaddressescitedin this book.
Gerhard Nahler
Contents
Dictionaryofpharmaceutical medicine
Abbreviations/acronyms 131
Selected bibliography 153
Importantaddresses 156
abbreviated new drug application Application for marketing
authorisationifadrughasalreadyreceivedapprovalundera
previous conventional NDA; important drug properties as
e.g. toxicity and safety have therefore already been docu
mented.
Aberdeendrugcodingsystem see CODE.
absoluterisk see RISK.
acceleratedapprovalprogram Theaverage duration for mar
ketingauthorisationintheUStakesmorethan20months;in
an accelerated approval program substances are classified
accordingtotheir therapeuticpotentialinP(priority)andS
(standard) substances;see NEWDRUGAPPLICATION.
acceleratedtesting seeSTRESSTESTING.
acceptable daily intake (ADI) Maximal amount of trace ele
ment,mineralandothersubstanceswhichcan be takenlife
longwithoutanyharmtoHEALTH;seealsoDEFINEDDAILYDOSE.
acceptablequalitylevel (AQL) defined asthe maximum per
centoferrorsthat,for purposesofcontrolsorsampling,can
beconsideredsatisfactoryasan averageofthetotalsystemor
process;see alsoAUDIT.
accrualrate see RECRUITMENT RATE.
accuracy Extent to which a measurement agrees with the
"true" value (which is never known) of the analyte being
assayed;a.reflectstheextentofasystematicERROR; theresult
obtainedwith the method in question isusually compared
with values obtained by an acceptable reference method;
resultsmaybe accurate,i.e.lyingwithinacceptablebounda
ries,butstillimprecise,becausetheyarewidelyscattered;see
MEASUREMENTPROPERTIES, PRECISION.
acknowledgements Authors ofpublications frequently use a.
to thankpersonswho made technicalorintellectual contri
butions to a study which were not deemed sufficient to
qualifyforAUTHORSHIP;itmaybequestionableifa.shouldalso
include peoplewho simply did their dailyjobswithoutany
specialcontributions.
active ingredient Pharmacologicallyactive part(s) ofa FORMU
LATION;themaximumacceptabledeviationinthea.i.content
ofa finished productmust not exceed ±5% at the time of
manufacture.
ac 2
activities ofdaily living Include typically the following activi
ties:sitting,puttingon socksand shoes,getting in/outofa
chair/car,standing, walking;in general these activitiesare
scored using an ORDINAL SCALE, ranging from e.g. "0", no
impairment, to "4",total inabilityto perform theactivity.
actual-treatedanalysis see PER-PROTOCOLANAL\SIS.
actuarialmethod see SURVIVALANAL\SIS.
addendum "minor" change to a PROTOCOL ofa CLINICAL TRIAL
(without consequences on ethical aspects);see also AMEND
MENT.
additiveeffect see INTERACTIONOFDRUGS, ERROR.
ADME abbr. absorption, distribution, metabolism, and/or
eliminationofadrugasaguidetothe DESIGNofearlyCLINICAL
TRIALSin PHASEIanddefinitivePHARMACOKINETICstudies.
admissioncriteria see ELIGIBILITYCRITERIA.
adverse drugevent (ADE) see ADVERSEREACTION, CONCOMITANT
EVENT, DRUGINJURY, PlIARMACOVIGILANCE.
adversedrugexperience(ADE) Can eitherbe expected(labeled)
which means that the event islisted in the current (FDA-)
approvedlabelingfor thedrugasapossible complicationof
druguseorunexpected(unlabeled),thelattertermincludesan
event that may differ from a labeled reaction because of
greaterseverityorspecificity(e.g.abnormalliverfunctionvs.
hepaticnecrosis); reportsofdeathfrom an ADEareconsid
eredunlabeled unlessthepossibilityofafatal outcomefrom
thatADEisstatedinthe labeling;seealsoADVERSEDRUGEVENT,
LABELING.
adverse drug reaction (ADR) CIOMS (COUNCIL FOR INTERNA
TIONAL ORGANISATIOf\;OF MEDICALSCIENCE) reports alwaysrefer
to a suspect reaction (in contrast to event or experience),
which implies that a physician orother professional health
care worker has judged it a reasonable possibility that an
observedclinicaloccurrencehasbeen caused byadrug;see
alsoADVERSEREACTION, DRUGINJURY.
adverseevent(AE) Anyundesirableexperienceoccurringtoa
subjectduring a clinical treatment, whetheror not consid
eredrelatedtothe(investigational)product(s);expectedAE
= eventwhich isalready known from previous experiences
and described in the Il'oVESTIGATOR'S BROCHURE or package
insert; techniques to evaluate AEs are e.g.: CASE CONTROL
STUDIES, POST-MARKETING SURVEILlANCE programmes, PRE
SCRIPTION-EVENT MONITORING, PRESCRIPTION-SEQUENCE ANAL\SES
etc.;whenan AEhas beenassessed (see STANDARDISEDASSESS-