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

179the date of their first marketing authorisation; (e.g. for additional5 years in US, Japan) usually up to a total length of 14 years; in ECcountries products can get a 5 year certificate, and a 15 years protectionperiod; transition periods are variable and start between 1January 1982 and 1 January 1988; there is no unitary European spc,but national ones only.supportive data Information on efficacy and safety not accepted aspivotal and therefore not central to new drug application.suppressor gene A gene that can reverse the effect of a mutation inother genes.suprabioavailability The new product displays a bioavailability appreciablylarger than the approved product; reformulation to alower dosage strength assuring therapeutic equivalence will benecessary; → see also pharmacokinetic, bioavailability.surface → see body surface.surrogate FDA: non-clinical measure that can reliably predict clinicalchanges within a reasonable amount of time; → see also biomarker,outcomes research, surrogate endpoint, surrogatemarker.surrogate endpoint = substitute/prognostic parameter for a clinicalendpoint; instead of the (clinical) event itself an event directlyrelated to it is recorded that indicates presence or worsening of aclinical condition in a clinical trial, e.g. cataract surgery insteadof the diagnose cataract, dispensing of an antidepressant for depressiveillness, specific markers or abnormal lab values reflectingprogress, a.s.o.; s.e. are measured to get faster results in clinicaltrials, whereby the presence in a high percentage of the patientsis a prerequisite; surrogate endpoints are frequently used in earlyphase of clinical development, e.g., phase IIa; → see also acceleratedapproval program, surrogate marker, surrogate.surrogate marker Measurement of a biological variable instead ofthe clinical condition, e.g. Magnetic Resonance Imaging instead ofpatient’s disability in multiple sclerosis, tumor markers instead oflesions, forced expiratory volume in 1 second/FEV 1in lung diseases,CRP or ESR in inflammatory diseases; → see also surrogateendpoint.surveillance → see prescription-event monitoring, spontaneousreporting.survival analysis syn. life-table analysis; statistical technique forcalculating the probability of developing a given outcome (death,relapse, medical intervention, a.s.o.), taking into account the durationof follow-up; s.a. can be used to examine the distribution oftime to occurrence of any dichotomous outcome and applies toboth observational and experimental clinical trials; most commonsur