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

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100isoquality intentions concerning the production of pharmaceuticals,medical devices etc. or provision of services; EN 29000 is the identicalEuropean copy of the international standard ISO 9000; ISO9000 standards must be followed in order to trade freely withinthe EC nations; companies that are not ISO 9000 accredited mayneed to undergo quality audits by every other company with whichthey trade; both ISO 9000 and FDA’s good manufacturing practiceregulations follow the same general guidelines; registration to ISO9000 follows from satisfactory audit by certification bodies (e.g.BSI Quality Assurance, Lloyds Register Quality Assurance) with aninitial total assessment (repeated every 3 rd year), followed by sixmonthly partial assessments; → see also audit, good manufacturingpractice, international organization for standardization,quality assurance, total quality management.ISO 9000-3 Standard on quality management and quality assurancefor the development, supply, and maintenance of computersoftware, published by the International Organization for Standardization(ISO) in Geneva 1991; → see also ieee standard 1062-1993, interrnational organization for standardization.ISO 9001 Quality systems – model for quality assurance in designdevelopment, production, installation and servicing; for use whenconformance to specified requirements is to be assured by thesupplier during several stages which may include design/development,production, installation and servicing; first edition 1987;→ see also interrnational organization for standardization.ISO 9002 Quality systems – Model for quality assurance in productionand installation; for use when conformance to specified requirementsis to be assured by the supplier during production andinstallation; → see also interrnational organization for standardization.ISO 9003 Quality systems – Model for quality assurance in final inspectionand test; for use when conformance to specified requirementsis to be assured by the supplier solely at final inspection andtest; → see also interrnational organization for standardization.ISO/DIS 10011-2 Guidelines for auditing quality systems – qualificationcriteria for auditors (1989); → see also interrnational organizationfor standardization, audit.
101joint-marketing One product is sold by two companies under twotrademarks; → see also competition law, co-promotion.joint-venture → see: strategic alliancejoi
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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
Page 60 and 61: 50devcomparison, e.g. two group par
Page 62 and 63: 52diadiagnostic A product used for
Page 64 and 65: 54disdisqualification rate → see
Page 66 and 67: 56drudrug FDA: (1) substance recogn
Page 68 and 69: 58druTable 1Determining the Probabi
Page 70 and 71: 60ecbEC birth date First date on wh
Page 72 and 73: 62effensures and declares that the
Page 74 and 75: 64eleelectronic signature OECD: “
Page 76 and 77: 66enzinformation about the physical
Page 78 and 79: 68ethofficial action indicated; OAI
Page 80 and 81: 70excglidants (improving powder flo
Page 82 and 83: 72expin tabular or in graphic form
Page 84 and 85: 74facfactorial design D. where it i
Page 86 and 87: 76foomised, IIa walking distance >
Page 88 and 89: 78gamgamma error syn. type III erro
Page 90 and 91: 80gengeneric name syn. internationa
Page 92 and 93: 82googood clinical research practic
Page 94 and 95: 84halhalf life (t 1/2) Time within
Page 96 and 97: 86heaprofiles are designed for a wi
Page 98 and 99: 88icdICD-9 code International Class
Page 100 and 101: 90impthey choose to submit manuscri
Page 102 and 103: 92infbe given to the person signing
Page 104 and 105: 94insincluding at least one member
Page 106 and 107: 96intinternal audit → see audit.i
Page 108 and 109: 98invinvestigational drug syn. inve
Page 112 and 113: 102kapKaplan-Meier method syn. prod
Page 114 and 115: 104lablabelling FDA: “all labels
Page 116 and 117: 106lifprotection; since costs of la
Page 118 and 119: 108identified amount produced in a
Page 120 and 121: 110masmaster file → see Drug Mast
Page 122 and 123: 112medto the FDA by phone as soon a
Page 124 and 125: 114micby chemicals; → see also an
Page 126 and 127: 116monmonitor’s visit log list sy
Page 128 and 129: 11890 days), certifies the dossier
Page 130 and 131: 120natnational drug list syn. natio
Page 132 and 133: 122nofno-fault insurance syn.: no-f
Page 134 and 135: 124null-hypothesis (Ho) Statistical
Page 136 and 137: 126oncgests carcinogenic potential,
Page 138 and 139: 128outintroduced in Japan (limit: J
Page 140 and 141: 130pacpackage insert → see patien
Page 142 and 143: 132patpatient log list → see subj
Page 144 and 145: 134perthe market authorisation stat
Page 146 and 147: 136phaing price (USA 42%, Western a
Page 148 and 149: 138phatics and observational, non-e
Page 150 and 151: 140pheunder non-trial conditions; t
Page 152 and 153: 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 (
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150rejected and not the confidence
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152quatice; it operates upon all me
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154racracemate equimolar mixture of
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156rarall member states; after the
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158refreference pricing syn. fixed
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160reprepeated measures design D. w
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162ressize of one or more measurabl
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164rougastric emtying; dermal: lipi
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166safsafety alert Voluntary commun
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168serof true positive plus false n
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170sinsingle-dose toxicity syn. acu
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172sporive from a study or any orga
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174staical trials; SOP should descr
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176strstrength of medication; amoun
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178subsubject identification code l
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180methods of s.a. are the actuaria
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182three-way crossover design → s
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184toxthe FDA still requests 12 mon
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186treon how long the desired effec
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188vacvaccine A preparation that co
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190as ideal drug and is distributed
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192welestablished in previous ratin
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194whowhich can be used because dru
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196xenotransplantation Animal-to-hu
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198zero order kinetics → see kine
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200ADRADRACADROITADRRSADsAdSADTAEAE
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202ASCOASIASMFASRAS-ODNATCATCCAUCAV
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204CADD Computer Assisted Drug Desi
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206ChBCHDCHFCHMPCHOCHOPCICIBCIMCIOM
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208CRUCSCSACSDCSMCSRCSPCTCTACTCCTDC
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210DOBDoHD.P.DPMDRFDRLDSDDSMDSMBDSR
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212EPDEPhMRAEPLCePROEPSERERCPESCOPE
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214GHTFGIGILSPGITGLCGMGMCGM-CSFGMMG
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216ICD-9ICD-10ICDAICD-OICEICGEBICHI
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218LMWHLOCFLPILPOLRECLRTILUTILUTSLV
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220NANACDSNADNADANAFNAFTANAINAPMNAS
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222PCAPatient Controlled AnalgesiaP
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224RCGPRCCRCTR&DRDARDERDSREMRFPRHAR
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226StpSURSUSARSuspSVTTAATAPTBTBITCI
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228Selected bibliographyEuropean Co
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230WHOAdverse reaction dictionary.
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232Drug Research & Development1. Ph
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2344. The Practice of Medicinal Che
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2366. Practical Statistics for Medi
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2386. Medical Decision MakingSox H.
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240IFAPPInternational Federation of
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242http://www.infobiogen.fr/service
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244http://medicine.iupui.edu/flockh
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220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

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