220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

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194whowhich can be used because drugs on the main list cannot be madeavailable or are known to be ineffective/inappropriate in a givenindividual (e.g. reserve antibiotics) or which are used in rare disordersor in exceptional circumstances.WHO performance status scale syn. ECOG-Zubrod scale; → seeperformance status; → see also ordinal scale.WHO-toxicity scale A 5-grade system (0–4) for reporting of acuteand subacute toxic effects of cancer treatment.willingness to pay (WTP) Maximum amount that a person is willingto pay to achieve a particular good health state or outcome, or toavoid a particular bad health state or outcome, or to decrease itsprobability; → see economic analysis.withdrawals (1) subjects not finishing a clinical trial for studyrelated reasons and which are therefore excluded by the trialist,e.g. due to adverse effects, treatment failure or deterioration ofpatient’s condition resp. or major protocol violations, e.g. noncompliance,“no-shower” for clinical appointments, pregnancyor other conditions which render patients ineligible, included becausethey were already ineligible to enter and should have beenexcluded initially; together with dropouts they represent a considerablesource of bias in a trial; a standard “withdrawal form” exploringreasons and circumstances should therefore be an integralpart of each CRF; there should always be a follow-up of patientswithdrawn; furthermore statistical analysis should include all subjectsentering a study (intent-to-treat principle); → see alsodisclosure procedure, loss to follow-up, run-in period; (2)pharmaceutical products withdrawn from sale (voluntary) or MAhas not been renewed; between 1961 and 2007 at least 120 drugshave been withdrawn for safety reasons (about 2 to 7 per year, 50%within 5 years post marketing authorization); in the EC (EMEA), atotal of 31 medicinal products was withdrawn or MA was not renewedbetween 2001 and 2005; → see also rebound effect, recall.withdrawal trial → see design.within-subject design syn. within patient comparison, intra-individualcomparison; opp. between-subject d.; each subject (patient)serves as his own control, e.g. in cross-over d. or singlecase studies; furthermore measuring changes from baseline(run-in phase) usually reduces drastically the number of patientsrequired, e.g. pretreatment blood pressure measurements in anithypertensivetrials; → see also design.women Most drug laws regulate the inclusion of w. in clinical trials,discouraging recruitment in child bearing age, at least untilteratogenicity data from animal studies are available; revised NIH-
195guidelines (1994) require among others that “women and minoritiesand their subpopulations are included in all human subjectresearch”, and that they are “included in phase III clinical trialsso that valid analysis of differences in intervention effect can beperformed”; most laws require now pregnancy testing before andin regular intervals, verification of contraceptive use, and detailedinformation in the informed consent procedure; despite genderdifferences in drug action, analyses of data by sex are still rarelyrequested; → see also labelling.work breakdown structure (WBS) Hierarchical organisation oftasks; → see also project management.World Health Organisation (WHO) Currently more than 180 statesare members of the WHO.wor
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Gerhard NahlerDictionary ofPharmace
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ForewordIn the beginning was the wo
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Foreword of the 1st editionThe evol
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IXPreface of the 1st editionFinally
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1abbreviated new drug application A
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3actual-treated analysis syn. as-tr
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5of a sign or symptom which is easi
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7allele frequency Often called gene
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9anecdotal study → see observatio
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12audaudit trail → see data trail
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14bento calculate the posterior odd
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16biolent; FDA: “bioequivalent dr
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18bloblock size Size of consecutive
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20caccachexia def. unintended and p
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22cascer patients); the method for
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24cemCE marking (of a medical devic
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26chrtain DNA and proteins; genes a
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28cleclerical error syn. key-punch
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30clijournals: Writing and editing
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32coithis treatment (e.g. to follow
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34comreporting”; → see also see
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36connal data. It should be possibl
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38conof exposure-outcome associatio
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40coopolymer matrix), wax matrices,
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42cosare increasingly used to facil
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44cumcumulative incidence Number of
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46datdata dredging Multiple, exhaus
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48datto confirm that the correct pr
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50devcomparison, e.g. two group par
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52diadiagnostic A product used for
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54disdisqualification rate → see
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56drudrug FDA: (1) substance recogn
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58druTable 1Determining the Probabi
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60ecbEC birth date First date on wh
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62effensures and declares that the
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64eleelectronic signature OECD: “
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66enzinformation about the physical
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68ethofficial action indicated; OAI
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70excglidants (improving powder flo
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72expin tabular or in graphic form
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74facfactorial design D. where it i
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76foomised, IIa walking distance >
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78gamgamma error syn. type III erro
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80gengeneric name syn. internationa
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82googood clinical research practic
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84halhalf life (t 1/2) Time within
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86heaprofiles are designed for a wi
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88icdICD-9 code International Class
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90impthey choose to submit manuscri
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92infbe given to the person signing
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94insincluding at least one member
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96intinternal audit → see audit.i
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98invinvestigational drug syn. inve
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100isoquality intentions concerning
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102kapKaplan-Meier method syn. prod
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104lablabelling FDA: “all labels
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106lifprotection; since costs of la
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108identified amount produced in a
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110masmaster file → see Drug Mast
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112medto the FDA by phone as soon a
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114micby chemicals; → see also an
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116monmonitor’s visit log list sy
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11890 days), certifies the dossier
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120natnational drug list syn. natio
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122nofno-fault insurance syn.: no-f
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124null-hypothesis (Ho) Statistical
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126oncgests carcinogenic potential,
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128outintroduced in Japan (limit: J
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130pacpackage insert → see patien
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132patpatient log list → see subj
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134perthe market authorisation stat
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136phaing price (USA 42%, Western a
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138phatics and observational, non-e
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140pheunder non-trial conditions; t
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142pooing conventional procedures o
Page 154 and 155: 144powoccurs; → see also Individu
Page 156 and 157: 146preassessments are harmonised (e
Page 158 and 159: 148proproduct licence application (
Page 160 and 161: 150rejected and not the confidence
Page 162 and 163: 152quatice; it operates upon all me
Page 164 and 165: 154racracemate equimolar mixture of
Page 166 and 167: 156rarall member states; after the
Page 168 and 169: 158refreference pricing syn. fixed
Page 170 and 171: 160reprepeated measures design D. w
Page 172 and 173: 162ressize of one or more measurabl
Page 174 and 175: 164rougastric emtying; dermal: lipi
Page 176 and 177: 166safsafety alert Voluntary commun
Page 178 and 179: 168serof true positive plus false n
Page 180 and 181: 170sinsingle-dose toxicity syn. acu
Page 182 and 183: 172sporive from a study or any orga
Page 184 and 185: 174staical trials; SOP should descr
Page 186 and 187: 176strstrength of medication; amoun
Page 188 and 189: 178subsubject identification code l
Page 190 and 191: 180methods of s.a. are the actuaria
Page 192 and 193: 182three-way crossover design → s
Page 194 and 195: 184toxthe FDA still requests 12 mon
Page 196 and 197: 186treon how long the desired effec
Page 198 and 199: 188vacvaccine A preparation that co
Page 200 and 201: 190as ideal drug and is distributed
Page 202 and 203: 192welestablished in previous ratin
Page 206 and 207: 196xenotransplantation Animal-to-hu
Page 208 and 209: 198zero order kinetics → see kine
Page 210 and 211: 200ADRADRACADROITADRRSADsAdSADTAEAE
Page 212 and 213: 202ASCOASIASMFASRAS-ODNATCATCCAUCAV
Page 214 and 215: 204CADD Computer Assisted Drug Desi
Page 216 and 217: 206ChBCHDCHFCHMPCHOCHOPCICIBCIMCIOM
Page 218 and 219: 208CRUCSCSACSDCSMCSRCSPCTCTACTCCTDC
Page 220 and 221: 210DOBDoHD.P.DPMDRFDRLDSDDSMDSMBDSR
Page 222 and 223: 212EPDEPhMRAEPLCePROEPSERERCPESCOPE
Page 224 and 225: 214GHTFGIGILSPGITGLCGMGMCGM-CSFGMMG
Page 226 and 227: 216ICD-9ICD-10ICDAICD-OICEICGEBICHI
Page 228 and 229: 218LMWHLOCFLPILPOLRECLRTILUTILUTSLV
Page 230 and 231: 220NANACDSNADNADANAFNAFTANAINAPMNAS
Page 232 and 233: 222PCAPatient Controlled AnalgesiaP
Page 234 and 235: 224RCGPRCCRCTR&DRDARDERDSREMRFPRHAR
Page 236 and 237: 226StpSURSUSARSuspSVTTAATAPTBTBITCI
Page 238 and 239: 228Selected bibliographyEuropean Co
Page 240 and 241: 230WHOAdverse reaction dictionary.
Page 242 and 243: 232Drug Research & Development1. Ph
Page 244 and 245: 2344. The Practice of Medicinal Che
Page 246 and 247: 2366. Practical Statistics for Medi
Page 248 and 249: 2386. Medical Decision MakingSox H.
Page 250 and 251: 240IFAPPInternational Federation of
Page 252 and 253: 242http://www.infobiogen.fr/service
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244http://medicine.iupui.edu/flockh
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