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

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

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

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110masmaster file → see Drug Master File, Trial Master File.master plan → see study list.master record → see device master record.matched pairs → see minimization, randomisation.maximum acceptable deviation (active ingredient content) → seeactive ingredient, radiopharmaceutical.maximum acceptable difference (MD) Largest true difference betweentreatments that a subject in the trial should be expected toaccept and yet continue in the trial.maximum non-lethal dose (MNLD) Highest single dose which doesnot induce death in animals; has replaced calculation <strong>of</strong> LD-50values.maximum repeatable dose (MRD) Dose which provides the firstevidence <strong>of</strong> significant toxicity whereby the substance is administeredin increasingly larger dosages – each three to four days – tothe same group <strong>of</strong> animals; → see also toxicity tests.maximum tolerated dose (MTD) Dose which provides the firstevidence <strong>of</strong> treatment limiting toxicity; refers to: (1) moderate decreasein weight gain <strong>of</strong> animals, not exceeding 10%, and usuallydetermined on the base <strong>of</strong> results <strong>of</strong> 90 day studies; (2) anticancerdrug evaluated in phase i patient trials in oncology; → see noel,toxicity tests.maximum tolerated systemic exposure (MTSE) Dose escalation strategyin phase I clinical trials for drugs likely to have a clear concentration-effectrelationship; → see also continuous reassessmentmethod (CRM), dose escalation, fibonacci search scheme,pharmacokinetically guided dose escalations (PGDE).mean Arithmetic mean: average <strong>of</strong> a number <strong>of</strong> values (the sum <strong>of</strong>the values divided by the number <strong>of</strong> observations, X = (x1+x2+ …xn)/n; the geometric mean is defined as the n-root <strong>of</strong> the product<strong>of</strong> the values, lgX = (lgx1+lgx2+ … lgxn)/n; if the data are normallydistributed the mean and median coincide; → see also mode, distribution,standard error.mean blood pressure (MBP) → see mean arterial blood pressure.mean arterial blood pressure (MAP) defined as: diastolic BP +1/3x(systolic – diastolic BP).measurement properties Accuracy, consistency, precision, reliability,reproducibility, validity, variability.median midmost value <strong>of</strong> a distribution; 50% <strong>of</strong> n observations havehigher, and 50% lower values, therefore = (n + 1)/2; → see alsomean, mode, distribution.medical audit Systematic, critical analysis <strong>of</strong> the quality <strong>of</strong> medicalcare, including the procedures used for diagnosis and treatment,

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