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

113memorandum of understanding (MOU) FDA: allows mutual recognitionof inspections.meta-analysis syn. pooled analysis, overview analysis; statisticalanalysis combining or integrating data from two or moreindependent trials of the same treatment, with similar selectioncriteria, and measuring identical parameters by comparablemethods; in general m.a. are performed for drawing global conclusionsconcerning safety and efficacy; when selecting studiesfrom the literature, m.a. can be subject to severe publication bias;selection for inclusion in this kind of analysis should thereforeproceed according to preset standards; a list of all included aswell as excluded studies should always be presented and thesensitivity of the results of the m.a. against inclusion or exclusionof specific studies demonstrated; dangers: m.a. may invitefalse confidence in results where data differing in quality andpatient groups differing in properties are combined; relationshipbetween frequencies can be presented either as difference or asratio (odds ratio).meta-data data about data.metabolism All biochemical activities carried out by an organism tomaintain life; biochemical transformation of a drug; usually thebody makes a drug more water soluble so the drug can be eliminatedmore rapidly via kidney and urine; common reactions of biotransformationinclude oxidation/hydroxylation, reduction andhydrolysis, or synthetic processes such as conjugation; for someenzymes genetic polymorphism has been described; e.g. for 4 outof approximately 8 isoenzymes of cytochrome P-450 (among African-Americans,1.9% lack debrisoquine hydroxylase CYP2D6 and18.5% mephenytoin hydroxylase CYP mp, essential for metabolisationof psychotropics) compared with 0–2.4% (17.4–22%) Asiansand 3–8.9% (2.5–6.7%) Caucasians; important differences havealso been reported for N-acetytransferase activity (NAT-2): 62%of African-Americans lack the enzyme and are poor metaboliserscompared to 5–21% Asians and 49–74% Caucasians; in these subjectsfor example isoniazid, a drug used in treating tuberculosis,causes a high incidence of peripheral neuropathy; → see adme,ethnic differences, pharmacogenetics, poor metaboliser.metabolite A substance produced during or taking part in metabolism.Michaelis-Menten kinetics → see kinetic.microbiology Study of living organisms and viruses, which can beseen only under a microscope; → see also bacterium.micronucleus test Short term in vivo assay in rodent bone marrowin order to detect chromosomal damage to the mitotic apparatusmic