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

3actual-treated analysis syn. as-treated analysis; opposite to intentto-treata.; → see intent-to-treat analysis, per-protocolanalysis.actuarial method → see survival analysis.acute toxicity syn. single dose toxicity; → see toxicity.adaptation In the evolutionary sense, some heritable feature of anindividual’s phenotype that improves its chances of survival andreproduction in the existing environment.addendum “minor” change to a protocol of a clinical trial (withoutconsequences on ethical aspects); → see also amendment.additive effect → see interaction of drugs, error.adjuvant chemotherapy Systemic chemotherapy administered afterthe use of definitive loco-regional treatment (resection of all knowntumor); histological assessment of the resected tumor specimenallows allocation of a pathological stage, thus predication of likelyoutcome without further intervention; → see also neoadjuvantchemotherapy.ADME abbr. absorption, distribution, metabolism, and/or eliminationof a drug as a guide to the design of early clinical trialsin phase i and definitive pharmacokinetic studies.administration of a substance can be enteral (directly into the gastrointestinaltract), i.e. oral, rectal, sublingual, nasal or parenteral(bypassing the gastrointestinal tract), i.e. intravenous, intramuscular,subcutaneous, intraarterial, intraperitoneal etc.; → see adme,route of administration.admission criteria → see eligibility criteria.adverse drug event (ADE) → see adverse reaction, concomitantevent, drug injury, pharmacovigilance, rule-of-three.adverse drug experience (ADE) Can either be expected (labeled)which means that the event is listed in the current (FDA-) approvedlabeling for the drug as a possible complication of drug useor unexpected (unlabeled), the latter term includes an event thatmay differ from a labeled reaction because of greater severity orspecificity (e.g. abnormal liver function vs. hepatic necrosis); reportsof death from an ADE are considered unlabeled unless thepossibility of a fatal outcome from that ADE is stated in the labeling;→ see also adverse drug event, labeling.adverse drug reaction (ADR) ICH: (pre-approval clinical experience):“all noxious and unintended responses to a medicinal productrelated to any dose shoud be considered adverse drug reaction”;WHO/ICH (marketed medicinal product): “a response to adrug which is noxious and unintended and which occurs at dosesnormally used in man for prophylaxis, diagnosis, or therapy of diseaseor for modification of physiological function”; CIOMS (coun-adv