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

107phases between their bilayers; single-layered liposomes are generally< 0.1–0.2 μm in size and good carriers of water-soluble drugs;their small size generally reduces their rate of elimination; multilayeredvesicles range from about 1–5 μm; with a higher proportionof lipid to aqueous phases due to multiple lipid bilayers, they aresuitable for transporting lipophilic drugs; they are more rapidlycleared from the body than single-layered l.; → see also drug deliverysystems, formulation.listed adverse drug reaction ICH: “An adverse reaction whosenature and severity are consistent with the information includedin the Company Core Safety Information; → see also unlistedadverse drug reaction.literature controls → see historical control.loading dose syn. priming dose; initial dose of a drug which ishigher than the maintenance dose; the concept being to achievea therapeutic concentration more rapidly in case of drugs with aslow elimination rate (e.g. therapy with tetracyclins, amiodarone,digitalis glycosides).local CRA → see clinical research associate.local delivery → see route of administration.log sheet Record of documents such as e.g. case record form, test articleaccountability form.loi DMOS abbr. “Diverses Mesures d’Ordre Social”; French law concerningfinancial benefits offered by the pharmaceutical industryto physicians and all other members of medical professions.loi Huriet syn. Loi Huriet-Serusclat; French Medicines Act whichcame into operation in December 1988.long-term use EC: “where the medicine is likely to be administeredregularly over a substantial period of life, i.e. continuously duringa minimum period of 6 months or frequently in an intermittantmanner so that the total exposure is similar”.Lorentz-formula For calculating the ideal body-weight (w) of asubject; for men: w = (height [cm] – 100) – ((height – 150)/4); forwomen: w = (height – 100) – ((height – 150)/2); → see also bodymass-index.loss to follow-up Patients lost to a clinical trial without knowing thereasons; sometimes also used to describe the total number of patientslost, i.e. not finishing a particular clinical trial (prematuretermination; the FDA (Clinical Guidance Document, 1994) suggeststhat loss to follow-up should be less than 20%; → see alsodrop-out, withdrawal.lot FDA: “batch, or a specific identified portion of a batch, havinguniform character and quality within specified limits; or, in caseof a drug product produced by continuous process, it is a specificlot