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

97now over 30 national associations from countries all over the worldhave become members of IFAPP.international non-proprietary name (INN) Name for a given drug(syn. generic name, opp. trade name); recommended by theWHO; at present more than 8,000 INNs have been published (in1991 this WHO-list contained 6,085 INNs, and 5,520 in 1988); INNsare, with some rare exceptions, identical to national names, e.g.local official names as British Approved Names (BAN), DénominationsCommunes Françaises (DCF), Japanese Adopted Names(JAN), United States Accepted Names (USAN), etc.International Organization for Standardization (ISO) Worldwidefederation of national standards bodies (ISO members), wherebymembers (governmental and non-governmental organizations)have the right to be represented on such committees; approvalof ISO procedures requires at least 75% approval by the membersvoting; standards are prepared by technical committees; appropriatestandard to apply depends on activities of the company;→ see therefore iso 9000, iso 9000-3, iso 9001, iso 9002, iso 9003,iso 10011-2.international prescribing information → see core data sheet.inter-observer reliability Degree to which one observer classifiedobservations in the same way as other observers; → see also inter-observerreliability, Κ statistic.interval scale Scale with measurements in definite units e.g. liters orml, kg, etc; → see also data.intervention trial syn. prevention trial; trial studying prevention ofdisease, either primary or secondary (e.g. reinfarction after infarction).intra-individual comparison → see within-patient comparison;Κ statistic.intra-observer reliability Degree to which one observer classifiedobservations in the same way at different points in time; → see alsointer-observer reliability, Κ statistic.invented name of a medicinal product, → see trade name.inventory → see drug accountability.investigational device exemption (IDE) Allows manufacturers toship and use imported devices intended solely for investigationaluse in human subjects, without having to first meet some FDArequirements; the IDE applies to all clinical studies that are undertakento gather safety and effectiveness data about a medicaldevice; only sponsors of studies involving devices with a significantrisk (as determined by the local institutional review board)are required to submit an IDE application to the FDA (CDRH) forapproval.inv