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

106lifprotection; since costs of launching and establishing a new productare far greater than the costs of maintaining one already onthe market there is a strong case for consciously extending the lifeof a product for as long as possible; increasing costs for R&D andbudget pressure on public health systems tend also to favour wellestablisheddrugs for standard therapy; potency and side effectsare often acceptable, whereas delivery and bioavailability may beless satisfactory; major extension strategies are: acceptance s. Thecustomer/doctor is encouraged to use the product (important:scientific and medical evidence); use expansion s. Broadening indications,providing evidence for safe use in other patient groups/higher dosages, line extension a.s.o.; profile enhancement s. Enhancementof the product-image; competitor response s. Predictionof and counteraction on competitor responses; cost-effectivenesss. Optimisation of effectiveness, minimisation of costs; → seealso formulation, innovative chemical entity, new chemicalentity, research and development.life event Major life events (such as illness, marriage, pregnancy,death of relatives, children, new job, quarrels with superiors, moveto a new home, vacations, loans taken, private bankruptcy etc.),can have effects on clinical outcomes and can bias results, esp. inquality of life studies; → see also bias.life-table analysis → see survival analysis.life-threatening FDA: “The patient was, in the view of the investigator,at immediate (emphasis added) risk of death from the reactionas it occurred, i.e., it does not include a reaction that, had it occurredin a more serious form, might have caused death.”Likert scale Usually a 3 or 5 point scale for categorical data (e.g.mild-moderate-sever); → see also visual analogue scale.Limulus Amebocyte lysate test (LAL) Test on the presence of bacterialendotoxins in drugs or devices in order to show effectiveness ofdepyrogenation techniques.linear analogue self assessment (LASA) → see visual analoguescale.linear correlation coefficient → see correlation coefficient.linear regression Process of fitting a straight line to two continuousvariables; mathematically: y = a + bx; b = regression coefficient;predicts, in contrast to correlation coefficient r, value of y from avalue of x; → see also correlation coefficient.line extension New commercial form of a marketed product, e.g. newdosage or application form, new galenical formulation a.s.o.; strategyused for life cycle management of a pharmaceutical product.liposome Vesicle constructed of phospholipid bilayers that allow thevesicles to mimic biological membranes; they contain aqueous