In the beginning was the word - and the foreword. Words are c- bined to sentences and eventually language. Words are listed in a dictionary and their meaning in building language are explained in a lexicon. In the life sciences - e. g. drug development sciences and pharmaceutical medicine - the analogies are evidenced by the - nomic library and patho-physiological function as the lexicon. In this transition from code to function integrated lexica pay a pivotal role for a faster understanding. The present updated version of this books combines dictionary and lexicon and provides the translational - derstanding of the complex drug development process. With a large number of new terms, their abbreviations and explanations in this complex interdisciplinary process a great number of different dis- plines and specialists need to be informed: they include physicians, pharmacists, biologists, chemists, biostatisticians, data managers, - formation specialists, business developers, marketing experts as well as regulators, financing specialists, healthcare providers and ins- ers in a continuous professional development mode. This lexicon is therefore a most suitable and economical tool for fast and conclusive information for all key-players in the development of medicines at the working place, in postgraduate training as well as during graduate education. This book is an indispensible aid in any medical library. Prof. Dr. med. Dr. h. c. Fritz R.
Auflage
Sprache
Verlagsort
Verlagsgruppe
Zielgruppe
Für Beruf und Forschung
Professional/practitioner
Editions-Typ
Maße
ISBN-13
978-3-211-89835-2 (9783211898352)
DOI
10.1007/978-3-211-89836-9
Schweitzer Klassifikation
abbreviated new drug application.- Aberdeen drug coding system.- abriged application.- absolute bioavailability.- absolute risk.- absorption.- accelerated approval program.- accelerated testing.- acceptable daily intake (ADI).- acceptable quality level (AQL).- accrual rate.- accuracy.- acid dissociation constant.- acknowledgements.- action letter.- active implantable medical device.- active (pharmaceutical) ingredient (API).- active medical device.- active site.- active substance.- activities of daily living (ADL).- actual-treated analysis.- actuarial method.- acute toxicity.- adaptation.- addendum.- additive effect.- adjuvant chemotherapy.- ADME.- administration.- admission criteria.- adverse drug event (ADE).- adverse drug experience (ADE).- adverse drug reaction (ADR).- adverse event (AE).- adverse event of special interest.- adverse event report format.- adverse experience (AE).- adverse reaction (ADR).- age.- age-specific rate.- air-lock.- AJCC Staging (= American Joint Committee of Cancer).- ALCOA.- algorithm.- allele.- allele frequency.- allelic exclusion.- allergen product.- allocation.- allogenic.- allosteric regulation.- Allotype.- alpha error.- alternative hypothesis (Ha).- alternative medicine.- alternative splicing.- amendment.- ames test.- amino acids.- analysis.- analysis certificate.- analysis of study results.- anatomical therapeutic chemical classification system (ATC).- anchored visual analogue scale.- anecdotal study.- aneugen.- animal pharmacology.- annual safety update report.- antagonism.- antibiotic.- antibody.- anticodon.- antigen.- antioxidant.- antisense drug.- antisense oligonucleotides (AS-ODNs).- antiseptic substance.- apheresis.- application.- application fee.- appointment log book.- approval.- archiving.- area under the curve (AUC).- assay.- assessement report (AR).- association study.- as-treated analysis.- ATC exemption scheme.- attack rate.- attributable risk.- audit.- audit certificate.- audit trail.- authorisation form.- authorship.- autoimmune disease.- autoimmunity.- average.- bacterium.- balanced study.- bar chart.- bar code.- baseline variables.- batch.- batch documentation.- batch number.- Bayesian adverse reaction diagnostic instrument (BARDI).- benefit-risk analysis.- Berkson's bias.- beta error.- between-subject design.- bias.- bibliographical application.- binary outcomes.- bioanalytical method.- bioavailability.- biobank.- Bioequivalence.- bioinformatics.- biologic equivalent.- biological medicinal products.- biological products.- biological rhythm.- biomarker.- biopharmaceutical.- biorepository.- biotechnology (Biotech).- birth control.- birth date.- black list.- blinding.- block size.- blood products.- body-mass-index (BMI).- body surface.- body water.- body weight.- Bonferroni correction.- boundary value.- brand name.- bridging study.- Broca-formula.- bug.- bug log.- bulk drug substance.- bulk product.- cachexia.- calibration.- CAMA.- CANDA.- CAPA.- Capaility Maturity Model (CMM).- CAPLA.- CAPLAR.- carcinogen.- carcinogenicity tests.- cardiac index.- carry-over effect.- carrier-based drug delivery.- case-control study.- case-fatality rate.- case record form.- case report form (CRF).- case series.- case-surveillance.- categorical data.- causality.- ceiling effect.- cell.- cell culture.- cell cycle.- cell line.- CE marking.- censored data.- central ethics committee.- centralised procedure.- certificate of destruction.- certified copy.- changing pattern.- chemical equivalents.- chemokins.- chemosensitizer.- chirality.- chromosomes.- chronic toxicity.- chronotherapy.- CIOMS.- CIOMS I form.- circadian rhythm.- citation style.- clastogen.- classification of recurrence.- clean area.- clearance (Cl).- clerical error.- clinical development plan.- clinical hold.- clinical investigation.- clinical program outline.- clinical research assistant (CRA).- clinical research associate (CRA).- clinical research coordinator (CRC).- clinical research executive (CRE).- clinical research manager (CRM).- clinical research organisation (CRO).- clinical significance.- clinical study.- clinical trial (CT).- clinical trial authorisation (CTA).- clinical trial certificate (CTC).- clinical trial compensation guidelines.- clinical trial coordinator (CTC).- clinical trial data base (CTDB).- clinical trial exemption (CTX).- clinical trial manager.- clinical trial manual.- clinical trial notification (CTN).- clinical trial report.- clinical trial status report.- clinical trial supplies.- clone.- cloning.- close down.- closed system.- close out visit.- closing meeting.- clusters.- Cockcroft formula.- code.- code breaking procedures.- codes of practice.- codon.- coefficient of variation (CV).- coenzyme.- cohort.- cohort study.- coinvestigator.- COLA design.- co-marketing.- combining of lab data.- Committee for Proprietary Medicinal Products (CPMP).- Committee on Safety of Medicines (CSM).- Committee for Veterinary Medicinal Products (CVMP).- Common Technical Document (CTD).- community based trials.- Company Core Data Sheet (CCDS).- Company Core Safety Information (CCSI).- comparator product.- compassionate investigational new drug.- compassionate use.- compensation for drug induced injury.- competition laws.- complementary medicine.- complete review letter.- compliance.- composite variable.- compulsory licensing (CL).- computer assisted new drug application.- computer assisted product licence application.- computer assisted product licensing application review.- computerised system.- concertation procedure.- concomitant event (CE).- concomitant medication.- condition.- conditional approval.- confidence interval.- confidence limits.- confidential disclosure agreement (CDA).- confidentiality.- confidentiality agreement.- confidentiality of personal data.- configuration.- confounder.- consent.- consent form.- consistency of data.- consumption.- Container closure system.- contingency fees.- contingency table.- continuation study.- continuous data.- continuous reassessment method (CRM).- contract CRA.- contract house.- contract research organisation (CRO).- contraindication.- control.- controlled clinical trial (CCT).- controlled drug.- controlled release form (CR).- cooperativeness.- co-payment.- co-promotion.- core protocol.- core safety profile (CSP).- correction.- correction log.- correction of errors.- corrective and preventive actions (CAPA).- correlation coefficient.- cosmetic.- costs.- COSTART.- cost/benefit analysis (CBA).- cost/consequence analysis (CCA).- cost/effectiveness analysis (CEA).- cost/minimisation analysis (CMA).- cost/utility analysis (CUA).- Council for International Organisation of Medical Sciences (CIOMS).- counterfeit medicine.- Covariate.- creatinine clearance (CCr).- CRF correction log.- critical path method (CPM).- critical term list.- cross contamination EC.- crossing over.- crossover.- cross-sectional study.- CTX-scheme.- cultural background.- cumulative incidence.- cure.- CUSUM plot.- cut-off date.- cytotoxic.- DAMOS (Drug Application Methodology with Optical Storage).- data.- data analyst.- data archiving.- data audit trail.- data base.- data capture document.- data clarification form (DCF).- data coding.- data collection form (DCF).- data dictionary.- data dredging.- data edit form.- data editing.- data entry.- data handling manual.- date lock-point (DLP).- data manager.- data mining.- data monitoring.- data protection act.- data quality.- data resolution form (DRF).- data and safety monitoring board (DSMB).- data sheet.- data trail.- data transfer.- data validation.- dead line.- Dear Doctor letter.- death rate.- debriefing meeting.- decentralised procedure.- dechallenge.- decision analysis.- decision tree.- Declaration of Helsinki.- defined daily dose (DDD).- delayed release.- delta value.- demographic data.- descriptive statistics.- design.- development.- development international birth date (DIBD).- development safety update report (DSUR).- device.- device master record (DMR).- diagnosis.- diagnostic.- diagnostic index.- dialysis.- diary card.- diastereoisomers.- dichotomous data.- digital signature.- diluants.- diploma in pharmaceutical medicine.- directive.- direct medical costs.- direct non-medical costs.- direct-to-consumer (DTC).- disabilities.- disclosure procedure.- discontinuation criteria.- disease.- disease free interval (DFI).- disease free survival (DFS).- disease management.- outcomes research.- disintegrants.- disintegration test.- disqualification rate.- dissolution test.- distomer.- distribution.- distribution of data.- documentation.- dosage regimen.- dose escalation study.- dose proportionality study.- dose response relationship.- dose titration study.- dosing schedule.- double blind.- double data entry.- double-dummy technique.- double masked.- draize tests.- dropouts.- drug.- drug abuse.- drug accountability.- drug channeling.- drug comparability study.- drug consumption.- drug delivery.- drug delivery systems (DDS).- drug dependence.- drug error.- drug evaluation cost.- drug experience report.- drug holiday.- drug injury.- drug interaction probability scale (DIPS).- drug list.- drug master file (DMF).- drug monitoring.- drug product.- drug registration fees.- drug safety monitoring (DSM).- drug sales.- drug safety unit (DSU).- drug substance.- drug safety updates.- drug utilisation review (DUR).- drug utilisation study.- Du Bois formula.- EC birth date.- EC declaration of conformity.- EC law.- ECOG performance status.- ecological fallacy.- ecological study.- economic analysis.- ecotoxicity.- EC type-examination.- EC type-examination certificate.- EC verification.- effect.- effectiveness.- effectiveness analysis.- effect modifier.- effect size.- effect size (SRM).- efficacy.- ejection fraction.- elderly.- electronic case report form (eCRF).- electronic data.- electronic data capture (e-DC).- electronic record.- electronic signature.- eligibility checklist.- eligibility criteria.- elimination.- emergency consent waiver.- emergency use.- emollient.- empiric recurrence risk.- EN 29000.- enantiomer.- endocannabinoides.- endorphins.- endotoxin test.- endpoint.- enrolment log.- enteral administration.- enteric coated tablet (ECT).- enteric coating.- enterohepatic circulation.- entry criteria.- environmental risk assessment.- enzyme.- epidemic.- epidemiology.- equipoise.- error.- error of measurement (E of M).- escape medication.- essential documents.- essential drug list (EDL).- essential requirements (ERs).- essentially similar products.- establishment licence application (ELA).- establishment inspection report (EIR).- ethical drug.- ethics committee (EC).- ethnic differences.- etiologic fraction (EF).- EU birth date (EBD).- EudraCT.- EudraVigilance.- European Medicines Evaluation Agency (EMEA).- European Pharmacopoeia (Eur Ph).- European Public Assessment Report (EPAR).- eutomer.- evaluation report.- event timing.- evidence based medicine (EBM).- evidence based prescribing.- excipient.- exclusion criteria.- excretion.- expanded-access program.- expected (listed) adverse event.- expedited drug development.- expedited reporting.- expedited review.- experimental drug.- experimental trial.- expert détaché.- expert report.- expert system.- expiration date.- expiration dating period.- expiry date.- exit interview.- explanatory trial.- expression.- extended release form.- extender analysis.- extension application.- extension protocol.- external audit.- extra incidence rate in non-vaccinated groups (EIRnv).- extra incidence rate in vaccinated groups (EIRv).- factorial design.- fast track procedure.- FDA 356h form.- FDA 482 form.- FDA 483 form.- FDA 484 form.- FDA 1571 form.- FDA 1572 form.- FDA 1639 form.- Fibonacci search scheme.- field study.- fifteen days report.- FIGO-staging.- final report.- findings.- finished product.- first-in-man study.- first-order kinetics.- first-pass effect.- fixed-payment system.- floor effect.- flow chart.- follow-up protocol.- Fontaine's stages.- food.- food supplement.- Food and Drug Administration (FDA).- forced licensing.- formulary.- formulation.- fraud.- freezing of data base.- functional food.- gamma error.- Gantt chart.- Gaussian curve.- Gehan's design.- gene.- gene expression.- gene mapping.- gene sequencing.- gene therapy.- genetic disease.- general sale list medicine (GSL).- generic.- generic application.- generic medicinal product.- generic name.- genetic code.- genetic engineering.- genie score.- genome.- genomics.- genomics therapy.- genotoxicity.- genotype.- geriatric evaluations.- geriatric population.- glidants.- global assessment variable.- glomerular filtration rate (GFR).- good clinical practice (GCP).- good clinical regulatory practice (GCRP).- good clinical research practice (GCRP).- good clinical trial practice (GCTP).- good laboratory practice (GLP).- good manufacturing practice (GMP).- good postmarketing surveillance practice (GPMSP).- good regulatory practice (GRP).- GP trial.- G-GRADE.- Graeco-Latin square.- GRAS-list.- Gross Domestic Product (GDP).- guidance.- guide.- guideline.- GXP.- half life.- harmonised standard.- handicap.- Havard style of citation.- Hawthorne effect.- hazard ratio.- healing.- health.- health care expenditure.- health care services.- health claims.- health expenditures.- health profile.- health-related quality of life (HRQOL).- health utilities index (HUI).- healthy-year equivalent (HYE).- Heaton-Ward effect.- heart insufficiency score.- Helsinki declaration.- herbal medicines.- heterocygote.- high level term.- high-tech medicinal products.- high-tech procedure.- historical control.- Hochberg correction.- home based CRA.- homocygote.- hospital file.- Huriet.- hybrid procedure.- Hygiene program.- ICD-9 code.- ICD-10 cade.- ideal body weight.- IEEE Standard 1062-1993.- IFAPP.- IFPMA.- IFPMA code of pharmaceutical marketing practices.- illness.- immediate release form (IR).- immune system.- immunity.- immunology.- immunmodulators.- immunotherapy.- immunotoxicity.- impact factor of journals.- impairments.- impurity.- imputabilty.- IMRAD.- incidence rate.- incident.- included term.- inclusion criteria.- inclusion period.- incubation period.- index patient.- IND safety report.- independent ethics committee (IEC).- indemnification.- individual case safety report (ICSR).- inevaluability rate.- inference statistics.- informed consent.- informed consent application.- initiation visit.- innovative chemical extension (ICE).- innovative new drug (IND).- inpatient.- in-process control.- inspection.- inspectional observations.- institution.- institutional review board (IRB).- insurance.- intangible costs.- integrated report.- intensive research design.- intent-to-treat analysis.- intent-to-treat list.- interaction of drugs.- interaction study.- interactive voice response system (IVRS).- interfering variable.- interim analysis.- inter-individual comparison.- intermediate product.- internal audit.- international birth date (IBD).- International Classification of Diseases.- International Conference on Harmonisation (ICH).- International Federation of Pharmaceutical Manufacturers Association (IFPMA).- International Federation of Pharmaceutical Physicians (IFAPP).- international non-proprietary name (INN).- International Organization for Standardization (ISO).- international prescribing information.- inter-observer reliability.- interval scale.- intervention trial.- intra-individual comparison.- intra-observer reliability.- invented name.- inventory.- investigational device exemption (IDE).- investigational drug.- investigational drug brochure.- investigational drug labelling.- investigational new drug (IND).- investigational medicinal product (IMP).- investigational medicinal product dossier (IMPD).- investigational plan.- investigator.- investigator's brochure (IB).- investigator's drug brochure.- investigator initiated trial (IIT).- investigator's manual.- investigator's meeting.- ion trapping.- ISO 9000/EN 29000.- ISO 9000-3.- ISO 9001.- ISO 9002.- ISO 9003.- ISO/DIS 10011-2.- joint-marketing.- joint-venture.- Kaplan-Meier method.- Karch and Lasagna classification.- Karnofsky performance status.- Keith-Wagener classification.- key efficacy criteria.- key-punch error.- kick-off symposium.- kinetic.- Korotkoff sound.- Koseisho.- ? statistic.- labelling.- labelling phenomenon.- label text.- label use.- laboratory normal range.- La Fontaine stages.- Lasagna's law.- last value carried forward (LVCF).- last visit carried forward (LVCF).- latent period.- Latin square.- Lead Ethics Committee.- learning effect.- legally acceptable representative.- lethality.- LD-10.- liability.- life-cycle management.- life event.- life-table analysis.- life-threatening.- Likert scale.- Limulus Amebocyte lysate test (LAL).- linear analogue self assessment (LASA).- linear correlation coefficient.- linear regression.- line extension.- liposome.- listed adverse drug reaction.- literature controls.- loading dose.- local CRA.- local delivery.- log sheet.- loi DMOS.- loi Huriet.- long-term use.- Lorentz-formula.- loss to follow-up.- lot.- lubricants.- magistral formula.- maintenance dose.- Managed Care Organisation (MCO).- manufacture EC (IV).- manufacturer EC (IV).- marginal costs.- Market.- marketing application.- marketing authorization.- marketing exclusivity.- marketing study.- masking.- master file.- master plan.- master record.- matched pairs.- maximum acceptable deviation.- maximum acceptable difference (MD).- maximum non-lethal dose (MNLD).- maximum repeatable dose (MRD).- maximum tolerated dose (MTD).- maximum tolerated systemic exposure (MTSE).- Mean.- mean blood pressure (MBP).- mean arterial blood pressure (MAP).- measurement properties.- Median.- medical audit.- medical culture.- medical device.- medical device reporting (MDR).- medical dictionary for drug regulatory activity (MedDRA).- medical management.- medical office trial.- medical registry.- medication error.- medication guide (US).- medicinal gas.- medicinal product.- Medicines Control Agency (MCA).- medwatch (US).- mee-too.- megatrial.- memorandum of understanding (MOU).- meta-analysis.- meta-data.- metabolite.- Michaelis-Menten kinetics.- microbiology.- micronucleus test.- microRNA.- migration study.- minimal clinically important difference (MCID).- minimal bactericidal concentration (MBC).- minimal inhibitory concentration (MIC).- minimal risk.- minimal toxic dose (MTD).- minimization.- minimum effective dosage (MED).- minimum inhibitory concentration (MIC).- minimum relevant difference (MIREDIF).- minorities.- Minnesota code.- misbranded drug.- misuse.- mode.- modified release.- monitor.- monitoring log list.- monitor's visit log list.- monoclonal antibody.- morbidity.- mortality.- mortality rate.- Muench's law.- multidose injection.- multidrug resistance (MDR).- multicentre trial (MCT).- multi-investigator study.- multinational trial.- multiple comparisons.- multi-state procedure.- Münch's law.- Murphy's law.- mutagenicity tests.- mutual recognition procedure (MRP).- NAFTA.- Nairobi principles.- named patient use.- nanoparticles.- national formulary.- Naranjo nomogram.- national drug list.- negative list.- neighborhood control subjects.- neoadjuvant chemotherapy.- nested case-control studies.- network chart.- networking.- new active substance (NAS).- new chemical entity (NCE).- new drug application (NDA).- new drug development plan (NDDP).- new molecular entity (NME).- New York Heart Association classification (NYHA).- Neyman fallacy.- NLN.- NOAEL.- N of 1 study.- no carbon required paper (NCR).- no-effect level.- NOEL.- no-fault insurance.- nominal data.- non-alpha site.- non-commercial clinical trial.- non-comparative study.- non-compliance.- non-conventional medicine.- non-evaluable patient.- non-experimental trial.- non-interventional trial.- non-new molecular entities (non-NME).- non-prescription drug.- non-renewal.- non-therapeutic study.- Nordic Council on Medicines (NLN).- Nordic Guidelines.- normal distribution.- normal range.- North American Free Trade Agreement (NAFTA).- note for guidance.- notice-of-change form.- notice-of-claimed investigational exemption for a new drug.- no-treatment-control.- nuisance variable.- null-hypothesis (Ho).- number of observations.- number of patients.- numerical pain scale (NPS).- Nuremberg Code.- Nutley system glossary.- obesity.- objective endpoint.- observational study.- odds.- odds ratio.- officinal formula.- off-label.- off-licence.- ointment.- old.- oldest old.- old substance.- oncogene.- oncogenicity studies.- oncology.- one sample multiple testing design.- one-sided test.- one-tailed test.- onset-adjusted incidence rate.- onset adjusted prevalence.- on-site audit.- open study.- open system.- optical activity.- optical character recognition.- optical mark recognition.- order effect.- ordinal data.- ordinal scale.- original medical record.- orphan diseases.- orphan drug.- outcome measurement.- outcomes research.- outliers.- outpatient.- overdose.- overhead.- over-the-counter (OTC).- overweight.- package insert.- packaging.- packaging material.- packaging system.- pairing.- paper trail.- parallel design.- parallel import.- parallel track policy.- parallel trade.- parametric test.- parent-child/foetus report.- parenteral administration.- Pareto's principle.- partition coefficient.- past medical history.- patent protection.- pathogen.- patient.- patient diary.- patient entry card.- patient file.- patient identification list.- patient information leaflet.- patient information sheet.- patient log book.- patient log list.- patient numbers.- patient package insert (PPI).- patient product information (PPI).- patient register.- patient report form (PRF).- patient screening log.- Parouzzi principle.- PDCA-cycle.- peak to trough concentration.- Pearson correlation coefficient.- Pediatric population.- percentile range.- performance assessment.- performance status.- periodic drug safety update report.- periodic safety update report (PSUR).- periodic site visit.- per-protocol analysis.- Perussel's law.- pharmaceutical benefit manager (PBM).- pharmaceutical company.- pharmaceutical equivalent.- pharmaceutical evaluation report (PER).- pharmaceutical expenditure.- Pharmaceutical Inspection Convention (PIC).- Pharmaceutical Manufacturers Association (PMA).- pharmaceutical market.- pharmaceutical medicine.- pharmaceutical quality assurance.- pharmacodynamic.- pharmacoeconomic study.- pharmacoepidemiology.- pharmacogenetics.- pharmacogenomics.- pharmacokinetic.- pharmacokinetically guided dose escalations (PGDE).- pharmacology.- pharmacopoeia.- pharmacovigilance.- pharmacy dispensing records.- pharmacy drug (P).- phase I.- phase II.- phase III.- phase IV.- phenotype.- physician investigator.- phytomedicines.- pill-counting.- pilot study.- pivotal data.- pivotal study.- pKa.- placebo.- placebo effect.- placing on the market.- plasmapheresis.- plausibility check.- play-the-winner allocation.- polymerase chain reaction (PCR).- pooled analysis.- pooling of lab data.- poor metaboliser.- population attributable risk.- population pharmacokinetics.- positive list.- post-approval research (PAR).- post-authorisation study (PAS).- post-authorisation safety study (PASS).- post-marketing observational study.- post-marketing safety study.- post-marketing surveillance (PMS).- powder inhaler.- power.- practice effect.- pragmatic analysis.- pragmatic/decision-making trial.- precision.- preclinical safety.- predicted environmental concentration (PEC).- predictive value.- preferred term.- pregnancy.- preinvestigation visit.- prelicensing agreement (PLA).- premarketing trial.- premarketing agreement (PMA).- premature termination.- premedication.- prescription.- prescription-event monitoring (PEM).- prescription only medication (POM, Rx) (UK).- prescription-sequence analysis (PSA).- prescription study.- preservatives.- prestudy documentation.- prestudy meeting.- prestudy visit.- presystemic hepatic elimination.- pretreatment phase.- pretrial data.- pretrial documentation.- pretrial visit.- prevalence rate.- prevention trial.- price control.- price regulatory scheme (PPRS).- primary endpoint.- priming dose.- principal investigator (PI).- prion.- probability.- procedures.- prodrug.- production.- product.- product liability.- product licence (PL).- product licence application (PLA).- product-limit method.- product recall.- product specification file.- programmatic error.- program evaluation technique (PERT).- project management.- project plan.- project book note.- prolonged release.- promoter.- promotional trial.- proportion.- proprietary medicinal product (PMP).- proprietary name.- prospective study.- protein.- protein binding.- proteomics.- protocol.- protocol deviation.- protocol violation.- p-value (p).- pyrogenicity test.- qualification.- qualified person.- quality variable.- quality-adjusted life-years (QALY).- quality assurance (QA).- quality assurance profile.- quality control.- quality of life (QL, QoL).- quality of life scale.- quality of life studies.- quantitative variable.- quarantine.- query log.- query resolution.- query resolution form.- Quetelet index.- quorum.- Q-value.- racemate.- racial differences.- radiopharmaceutical.- randomization.- randomization code.- randomized consent design.- randomized controlled clinical trial.- range.- rapporteur.- rare diseases.- rate.- rating scale.- raw data.- reaction.- Read clinical classification (RCC).- rebound effect.- rechallenge.- rechallenge trial.- recommended daily allowances.- recommended dietary allowances (RDA).- reconciliation.- recordkeeping.- record linkage.- record retention.- recovery.- recruitment period.- recruitment rate.- reference member state.- reference pricing.- reference safety information.- registry.- reference range.- regression coefficient.- regression paradox.- regression to the mean.- regulations.- reimbursement.- relational data base.- relative bioavailability.- relative risk.- release certificate.- reliability.- remote data entry.- renewal.- repeatability.- repeated dose toxicity.- repeated looks on data.- repeated measures design.- repeated significance testing.- repeat study.- replication study.- report.- reprocessing.- reproducibility.- reproductive toxicity.- rescue medication.- research and development (R&D).- research coordinator.- research nurse.- response.- response (cancer treatment).- restricted marketing authorization.- retain samples.- retest date.- retrospective study.- return.- ribozyme.- risk.- risk-benefit analysis.- risk factor.- risk management plan (RMP).- risk management system (RMS).- Ritchie index.- Rohrer index.- route of administration.- routine monitoring visit.- rule 80/125.- rule of three.- run-in phase.- safety alert.- safety analysis.- safety officer.- safety tests.- safety update report.- sales reps.- sample size estimation.- sampling error.- sanctions.- scales.- science impact index (SII).- score.- secondary attack rate.- secrecy agreement.- seeding activity.- selected list scheme (SLS).- selection criteria.- self-inspection.- self-medication.- self-regulatory industry control.- sensitivity.- serious adverse reaction.- sequence effect.- sequential design.- shelf life.- shift table.- side effect.- signal.- signal detection.- signal transduction.- significance level.- significant adverse event.- significant overdose.- signs.- sign test.- single-blind.- single case experiment.- single-dose toxicity.- single nucleotide polymorphism.- single-site trial.- site audit.- site management organisation (SMO).- site visit log.- skewness.- slow metaboliser.- slow release formulation (SR).- SNOMED.- source data.- source data verification (SDV).- source document.- specificity.- sponsor.- sponsor-investigator.- spontaneous adverse drug reaction report.- spontaneous notification.- spontaneous reporting scheme.- spontaneous report system.- spurious data.- square-root rule.- s-2 report.- stability test.- stabilizer.- staging.- standard deviation (SD).- standard error.- standard gamble.- standardized assessment of causality (SAC).- standardized decision aids (SDA).- standardized response mean (SRM).- standard operating procedures (SOP).- starting material.- start-up meeting.- statement of investigator.- statistical test.- steady state study.- steering committee.- stem cell therapy.- stereoisomer.- sterilisation.- sterility.- stochastic variable.- stopping rules.- stratification.- strategic alliance.- strength of medication.- stress testing.- strict liability.- study coordinator.- study duration.- study identification code.- study list.- study (site) coordinator.- study nurse.- study plan.- study progress report.- study status report.- study supplies.- subacute toxicity.- subgroup analysis.- subinvestigator.- subject.- subject enrolment log.- subject identification code.- subject identification code list.- subject screening log.- substance.- substantial evidence.- summary of product characteristics (SPC, SmPC).- sunset clause.- supplementary protection certificate (SPC).- supportive data.- suppressor gene.- suprabioavailability.- surface.- surrogate.- surrogate endpoint.- surrogate marker.- surveillance.- survival analysis.- sustained release.- switch.- symptoms.- synergism.- systematic error.- system-organ classes.- system-organ-class frequency (SOC).- tablet.- tablet excipients.- tachyphylaxis.- temporality.- termination visit.- test article.- test article accountability (TAA).- test-retest.- therapeutic equivalent.- therapeutic index.- therapeutic potential.- therapy management.- three-way crossover design.- time-event schedule.- time trade-off (TTO).- time-treatment interaction.- TNM-staging.- tolerance.- total organ carbon (TOC).- total quality management (TQM).- toxic dose level (TDL).- toxicity tests.- toxicokinetic.- trade name.- traditional herbal medicinal product.- transdermal delivery system (TDDS).- transdermal patch.- transgenic drug.- transition matrix.- transplantation.- treatment emergent signs and symptoms (TESS).- treatment IND.- treatment schedule.- treatment use.- trial.- trial design.- trialist.- trial management organisation.- trial master file (TMF).- tumour staging.- tumor suppressor gene.- turbo-haler.- two-stage design.- two-tailed test.- two-way crossover design.- type I error.- type II error.- type II variation.- type III error.- type of reaction.- unblinded study.- uncontrolled study.- underweight.- unexpected adverse event.- unlisted adverse drug reaction.- utilisation study.- utility measurement.- vaccine.- validation.- valid case analysis (VC-analysis).- validity.- Vancouver style of citation.- variability.- variable.- variance.- variation.- variation procedure.- virus.- visit log list.- visual analogue scale (VAS).- volume of distribution.- volunteer.- voluntary reporting (VR).- waist circumference.- waiver.- wash-out period.- Web-based data entry.- weight.- weighted average.- welfare.- well-being.- well-being scale.- well-established medicinal use.- wetting agent.- white-coat hypertension.- WHO-adverse reaction dictionary (WHO-ARD).- WHO-adverse reaction terminology (WHO-ART).- WHO-adverse reaction terminology list (WHO-ARTL).- WHO collaborating centre for international drug monitoring.- WHO-drug dictionary (WHO-DD).- WHO-drug reference list (WHO-DRL).- WHO-essential drug list (WHO-EDL).- WHO performance status scale.- WHO-toxicity scale.- willingness to pay (WTP).- withdrawals.- withdrawal trial.- within-subject design.- women.- work breakdown structure (WBS).- World Health Organisation (WHO).- xenotransplantation.- xenogeneic disease.- yellow card programme.- zero order kinetics.- Zubrod performance status.
