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

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16biolent; FDA: “bioequivalent drug products means pharmaceuticalequivalents or pharmaceutical alternatives whose rate andextent of absorption do not show a significant difference whenadministered at the same molar dose of the therapeutic moiety undersimilar experimental conditions, either single dose or multipledose”; → see also drug comparability study, biologic equivalent,pharmaceutical equivalent, rule 80/125, therapeuticequivalent.bioinformatics The discipline encompassing the development andutilization of computational facilities to store, analyze and interpretbiological data.biologic equivalent Dosage form that results in similar bioavailabilityregardless of the pharmaceutical formulation; → seealso essentially similar product, pharmaceutical equivalent,therapeutic equivalent.biological medicinal products Products such as vaccines, serums,toxins, allergen products and medicinal products derived fromhuman blood or plasma; → see also biopharmaceutical, establishmentlicence application.biological products Clinical trials with blood or biological productsas well as their registration are subject to special regulations in orderto assure absence of infectious contaminants (e.g. mandatoryscreening of blood donors).biological rhythm → see chronotherapy.biomarker Def (NIH): “characteristic that is objectively measuredand evaluated as an indicator of biologic processes, pathogenicprocesses or pharmacological response to a therapeutic intervention”;→ see also surrogate.biopharmaceutical Therapeutic product involving biotechnology,e.g. genetic engineering; product of biotechnological origin suchas antisense, genetic engineering, transgenics, involving manipulationof living organisms; → see also biological medicinalproduct, biotechnology.biorepository → see biobank.biotechnology (Biotech) Development of products by a biologicalprocess. Production may be carried out by using intact organisms,such as yeasts and bacteria, or by using natural substances (e.g. enzymes)from organisms; techniques involving manipulation of livingorganisms or substances made by living organisms, particularlyat the molecular genetic level; according to the U.S. Office of Scienceand Technology Policy, the term covers also “recently developedand newly emerging genetic manipulation techniques, such as recombinantDNA (rDNA), recombinant RNA (rRNA), and cell fusion,that are sometimes referred to as genetic engineering”; → see also
17biological medicinal product, biopharmaceutical, immunotherapy,transgenic drug, xenotransplantation.birth control Methods considered to be highly effective (failure rate
Page 3 and 4: Gerhard NahlerDictionary ofPharmace
Page 5 and 6: ForewordIn the beginning was the wo
Page 7 and 8: Foreword of the 1st editionThe evol
Page 9 and 10: IXPreface of the 1st editionFinally
Page 11 and 12: 1abbreviated new drug application A
Page 13 and 14: 3actual-treated analysis syn. as-tr
Page 15 and 16: 5of a sign or symptom which is easi
Page 17 and 18: 7allele frequency Often called gene
Page 19: 9anecdotal study → see observatio
Page 22 and 23: 12audaudit trail → see data trail
Page 24 and 25: 14bento calculate the posterior odd
Page 28 and 29: 18bloblock size Size of consecutive
Page 30 and 31: 20caccachexia def. unintended and p
Page 32 and 33: 22cascer patients); the method for
Page 34 and 35: 24cemCE marking (of a medical devic
Page 36 and 37: 26chrtain DNA and proteins; genes a
Page 38 and 39: 28cleclerical error syn. key-punch
Page 40 and 41: 30clijournals: Writing and editing
Page 42 and 43: 32coithis treatment (e.g. to follow
Page 44 and 45: 34comreporting”; → see also see
Page 46 and 47: 36connal data. It should be possibl
Page 48 and 49: 38conof exposure-outcome associatio
Page 50 and 51: 40coopolymer matrix), wax matrices,
Page 52 and 53: 42cosare increasingly used to facil
Page 54 and 55: 44cumcumulative incidence Number of
Page 56 and 57: 46datdata dredging Multiple, exhaus
Page 58 and 59: 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: “
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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
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144powoccurs; → see also Individu
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146preassessments are harmonised (e
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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
Page 252 and 253:
242http://www.infobiogen.fr/service
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244http://medicine.iupui.edu/flockh
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