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

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232Drug Research & Development1. Pharma 2020: The Vision which Path will you take?Price WaterhouseCoopers (2007) via web www.pwc.com/pharma2. The Future of Pharma R&D; Challenges and TrendsHarald Pacl, Gunter Festel, Günther Wess (Eds.)ISBN 3-00-014012-3 (Festel Capital, 2004)3. Guide to Drug Development. A Comprehensive Review and AssessmentSpilker BertISBN 10-7817-7424-1(Lippincott Williams and Wilkins, 2009)4. IBM Global Services: Pharma 2010: The Threshold of InnovationArlington S et al. (2004) via Web www.ccm/bcs/pharma 20105. The Investigators Guide to Clinical Research.A step by step guide to becoming a successful clinical investigatorDavid Gisberg/Robert WhitakerISBN 1-930-62430-1 (Pub Center Watch Publications 2002)6. Fraud and Misconduct in Biomedical ResearchWells Frank, Farthing Michael (4 th edition, Royal Society of MedicinePress, 2008)7. A Guide to the Global Pharmaceutical IndustryMark GreenerISBN 1-85978-498-4 (Informa Publishing Group Limited 2001)8. A Guide to Clinical Drug ResearchCohen Adam M. & Posner John2 nd editionISBN 0-792-36172-5 (Publ Kluwer Academic Publishers 2000)9. Expediting Drug & Biologics Development: A Strategic ApproachEd. Steve LinbergISBN 978-1882615766Pharmaindustry and Biotech Industry1. From Alchemy to IPO: The Business of BiotechnologyRobbins-Roth C.Basic Books; 1 st edition (April 10, 2001)
2332. Drugs-From Discovery to ApprovalNg, RWiley-Liss; 1 st edition (January 2, 2004)3. Science Business: The Promise, the Reality, and the Future of BiotechPisano G.Harvard Business School Press; 1 st edition (November 14, 2006)4. The Business of Healthcare InnovationBurns LRCambridge University Press; 1 st edition (September 19, 2005)5. Inside the FDA: The Business and Politics Behind the Drugs WeTake and the Food We EatHawthorne FWiley; 1 st edition (February 25, 2005)6. Building Biotechnology: Starting, Managing, and UnderstandingBiotechnology Companies – Business Development, Entrepreneurship,Careers, Investing, Science, Patents and RegulationsFriedman YThinkbiotech; 2 nd edition (August 1, 2006)7. Science Lessons: What the Business of Biotech Taught Me AboutManagementBinder G, Bashe PHarvard Business School Press (April 15, 2008)Pharmacology & Toxicology1. Clinical Pharmacokinetics: Concepts & Clinical ApplicationsRowland M(3 rd edition, Lippincott, Williams & Wilkins, Baltimore, March2006)2. Introduction to Pharmacokinetics and PharmacodynamicsTozer TN, Rowland MISBN 0781-75149-7 (Lippincott Williams & Wilkins, February2006)3. Good Practice of Clinical Drug TrialsSpriet A, Dupin-Spriet P3 rd edition, revised and expandedISBN 3-8055-77249 (Karger Publishers, 2005)
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
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IXPreface of the 1st editionFinally
Page 11 and 12:
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
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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
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 204 and 205: 194whowhich can be used because dru
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 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
Page 254: 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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