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

13bacterium Any of a large group of microscopic, single-cell organismswith a very simple cell structure; some manufacture their own foodfrom inorganic precursors alone, some live as parasites on otherorganisms, and some live on decaying matter.balanced study Trial in which numbers of patients and their characteristicsare equally distributed between groups e.g. similar numberof males/females, above 65 years a.s.o.; → see also stratification.bar chart → see gantt chart.bar code Codification system using a number of vertical black linesthe relative widths of which encode a specific information; usedalso for automated form reading by optical mark recognition;→ see also code.baseline variables Characteristics of a patient and of his/her diseasemeasured before the start (as soon as measurements are constant)of protocol treatment (baseline period); → see also runin-phase;b.v. are important for the evaluation of the results of aclinical trial to avoid regression to the mean or learning effects;→ see also placebo effect.batch syn. lot; EC (IV): “a defined quantity of starting material, packagingmaterial or product processed in one process or series ofprocesses so that it could be expected to be homogeneous”; FDA:“specific quantity of a drug or other material that is intended tohave uniform character and quality, within specific limits, and isproduced according to a single manufacturing order during thesame cycle of manufacture”; for stability testing batches shouldbe selected at random, with not less than 3 batches to be takenfor assessment of batch-to-batch variability; in order to be GMPcomplianta batch must have a minimal size of 100,000 units (e.g.,vials); → see also batch documentation, lot.batch documentation EC: set of documents making possible to tracethe history of the manufacture of a batch; b.d. needs to be retainedfor at least 1 year after the expiry date of the batch to which it relatesor at least 5 years after the certification, whichever is longer;samples of each batch must be retained for at least 1 year after theexpiry date, samples of starting materials (other than solvents,gases and water) used must be retained for at least 2 years after therelease of the product; → see also finished product.batch number EC (IV): “a distinctive combination of numbers and/or letters which specifically identifies a batch”; NLN: “a designationgiven by the manufacturer to a batch for the purpose of itsidentification”.Bayesian adverse reaction diagnostic instrument (BARDI) Bayesianbased approach for assessing drug-induced illness; the goal isbay