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

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2344. The Practice of Medicinal Chemistry2 nd edition, edited by Camille Georges WermuthISBN 978-0-12-374194-3 (Academic Press/Elsevier, Amsterdam,2008)5. Goodman & Gilman’s The Pharmacological Basis of TherapeuticsISBN 0-0713-5469-7 (McGraw Hill Publishing 2001)6. The Dose Makes the PoisonA plain language guide to toxicologyM Alice OttoboniISBN 0-442-02556-4 (Pub Van Nostrand Rheinhold, 1997)7. Presenting Toxicology ResultsHow to evaluate date and write reportsGerhard NohynekISBN 07848 0476 7 (Pub Taylor Francis 1996)Clinical Trial Design1. Modelling and Simulation in Clinical Drug DevelopmentRooney KL, Snoeck E, Watson PADrug Discov Today 2001, 6 (15), 802–8062. Biomarkers Definitions Working Group: Biomarkers and SurrogateEndpoints: Preferred Definitions and Conceptual FrameworkClin Pharmacol Ther 2001, 69 (3), 89–95.3. Fundamentals of Clinical TrialsFriedman L M, Furberg C D, DeMets D L. 3rd editionISBN 0-387-98586-7 (Springer-Verlag, New York, 1998)4. Clinical Trials: A Methodologic PerspectivePiantadosi S2 nd edition(John Wiley & Sons 2005)5. Clinical Trials: A Practical ApproachPocock S(John Wiley & Sons 1996; reprints only: 2002)6. Statistical Tables for the Design of Clinical StudiesMachin D, Campbell MJ(Oxford, Blackwell 1996)
2357. Guide to Clinical TrialsSpilker B(Lippincott Williamns & Wilkins 1991; reprint only 2000)8. The Use of Computer Assisted Design to Support Good ClinicalTrialsSnoeck E & Watson MBGood Clinical Practice Journal Vol 6, No 59. Randomised Controlled Trials: Questions, Answers and Musings,2nd EditionJadad AR, Enkin MWBMJ Books 200710. Designing Clinical Research; An epidemiologic approachHulley SB at al.Lippincott William Wilkins 3 rd Ed. 200611. Principles and Practice of Clinical Research, Second Edition(Principles & Practice of Clinical Research)Gallin JI, Ognibene FAcademic Press; 2 nd edition (May 8, 2007)Introduction to Biostatistics1. Primer of BiostatisticsStanton A. Glantz (McGraw-Hill Medical Publishing 2005)2. Systematic Reviews in Health Care. Meta-analysis in contextEgger M, Smith GD, Altman DGISBN 0-7279-1488-X (2 nd edition, BMJ Books 2001)3. Statistical Principles for Clinical Trials(ICH E9 step 5, Feb. 1998) via Web4. FAQ’s on Statistics in Clinical TrialsGrieve AP(Brookwood Medical Publications 1998)5. Using and Understanding Medical StatisticsMatthews DE, Farewell VT3 rd editionISBN 3-8055-6276(Karger Publishers 1996)
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Gerhard NahlerDictionary ofPharmace
Page 5 and 6:
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
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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
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 242 and 243: 232Drug Research & Development1. Ph
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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