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

95first glance – suitable for inclusion in a trial (although, in fact, onlypart of the subjects will give their consent or meet all inclusionand exclusion criteria); comments, why they were not eligibleshould be included in such a list; helpful for judgments concerninggeneralization of results (= external validity – degree to whichthe results valid in one patient population can be generalized toanother) and for adjusting selection criteria in case recruitment istoo slow; → see also enrolment log, sampling error.interaction of drugs If two or more drugs are given at the same timethe resulting effect(s) can either be the sum of the individual effects(additive e., no interaction), greater than the expected sum(multiplicative e., positive e., synergism) or less then expected(negative e., antagonism); designs suitable to detect interactionsor to study two or more treatments simultaneously are e.g. factorialdesigns, cross-over designs, a.s.o.interaction study Clinical (pharmacokinetic) study exploring theeffects of one drug on the activity or properties of another drug.Interactive (or Integrated) Voice Response System.interactive voice response system (IVRS) Computerised methodof randomisation, tracking drug assignment to patients, drug use,and maintenance of drug inventory at clinical sites as well as atdistribution centres; when a site needs to enroll a patient, the IVRSis contacted by public phone; the IVRS (which has a record of drugpackages at the site) instructs the site to assign pack number NNand patient number MM to the patient; → see also computerisedsystems, electronic data capture, remote data entry,source data.interfering variable → see confounder.interim analysis Statistical analysis which is performed before theplanned, total number of patients is recruited; for practical reasonsi.a. should not be done before at least 50 (–75)% of the total numberof planned cases are available; i.a. should always be planned inadvance, since the likelihood of a false positive result (alpha error)increases with the number of repeated tests (e.g. 10 repeatedtests on accumulating data at the 1% level of significance during atrial will be about the same as an overall test for the trial at the 5%level or 3 tests at the 5% level will change the overall significancelevel to 11%); i.a. demands therefore higher numbers of subjects;→ see also bonferroni correction, multiple comparisons.inter-individual comparison → see between-patient comparison.intermediate product EC (IV): “partly processed material which mustundergo further manufacturing steps before it becomes a bulkproduct”; → see also finished product, medicinal product.int