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

70excglidants (improving powder flow e.g. for capsule-filling machines,e.g. colloidal silicon dioxide, Ca silicate), wetting agents (improvingwater penetration, e.g. sodium lauryl sulfate, lecithin, polysorbate,polyoxyethylene stearate, sorbitan mono-oleate, polyethyleneglycol 6000), disintegrants (producing disruption of powdermass, e.g. sodium starch glycolate, alginic acid, croscarmellose,crospovidone, carmellose calcium, sodium carboxyaminopectin)and stabilizers (improving product stability, e.g. ascorbic acid,ascorbyl palmitate, malic acid, propyl gallate, sodium metabisulphite);→ see antioxidants, disintegrants, formulation, preservatives.exclusion criteria Criteria whereby an individual patient should notbe eligible for a specific treatment in a clinical trial; e.c. shouldbe used mainly to exclude patients likely to be harmed by one ofthe treatments or with conditons that may invalidate the results;→ see also inclusion criteria, eligibility checklist.excretion Elimination of a drug, either as metabolites or in unchangedform; the kidneys are the most important route for watersoluble substances (polar or ionized); some drugs are excretedinto bile and excreted via feces, some however can be reabsorbedinto the blood (enterohepatic circulation); volatile substances(anesthetics, toxic gases) can be excreted through the lungs; additionalroutes of excretion include sweat, saliva, tears, nasal secretionsand milk; → see also adme, clearance, half-life, firstpasseffect, glomerular filtration rate, kinetic.expanded-access program Many health authorities regulate formallythe conditions under which a larger population of patientscould gain expanded access to promising, new investigationaldrugs, early in the development process, e.g. for treatment of canceror AIDS; programs as available in the US are, e.g. treatmentind for serious or life-threatening diseases, compassionate use,emergency/investigator IND, open-label protocol (under an IND,to collect safety data); → see also orphan drugs; accelerated registrationprocedures may also exist.expected (listed) adverse event → see unexpected adverseevent.expedited drug development Alternative to standard drug developmentin order to make promising therapies available sooner; especiallyfor patients who can neither take standard therapy nor participatein controlled clinical trials; e.d.d. is intended to speed upclinical development, evaluation and marketing approval of newtherapies for patients with life-threatening or severely debilitatingillnesses, especially where no satisfactory alternative exists; → seealso community based trials, parallel track, treatment ind.