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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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23known response pattern, that is confirmed by dechallenge andrechallenge; probable = ADR as above but that has not been confirmedby rechallenge and that could not be reasonably explainedby the known characteristics <strong>of</strong> the patient’s clinical state; possible =ADR that follows a reasonable temporal sequence from administration,a known response pattern, but that could have been producedby the patient’s clinical state or other modes <strong>of</strong> therapy; conditional= ADR as above but that does not follow a known response patternto the suspected drug and that could not be reasonably explainedby the patient’s clinical state; doubtful = any reaction that does notmeet the criteria above; insufficient = there is insufficient data availableto make a comment; categories <strong>of</strong> the WHO are also widelyused (Certain – reasons and documentation given are sufficient tobe sure <strong>of</strong> a causal relationship (e.g. same reaction on re-exposure);Probable – reasons and documentation given are sufficient to assumea causal relationship, in the sense <strong>of</strong> plausible, conceivable,likely, but not necessarily highly probable; Possible – informationin the report is sufficient to accept the possibility <strong>of</strong> a causal relationship,in the sense <strong>of</strong> not being impossible or unlikely, althoughthe connection is uncertain or doubtful; Impossible/Unrelated – noreasonable temporal sequence from administration <strong>of</strong> the drug;event is clearly produced by the patient’s clinical state or othermodes <strong>of</strong> therapy; Unclassified/Unassessable – reports where causalityis, for one reason or another, not assessable, e.g. because <strong>of</strong>insufficient evidence, poor documentation or conflicting data; theFrench Ministry <strong>of</strong> Health demands use <strong>of</strong> an own, five-point causalityassessment method; in order to reduce inter-rater varianceswhich occur when c. assessment is done by ante mortem methodsstandardized decision aids (SDA) have been developed; → seealso Drug Interaction Probability Scale, Naranjo nomogram,standardized assessment <strong>of</strong> causality.ceiling effect opp. floor effect; treatment effects or scores (e.g.grip strength) that can be reached are limited, even when dosageor treatment duration a.s.o. is increased (e.g. analgesics); resultswill be heavily skewed (→ see skewness).cell The smallest structural unit <strong>of</strong> living organisms that is able togrow and reproduce independently.cell culture Growth <strong>of</strong> a collection <strong>of</strong> cells, usually <strong>of</strong> just one genotype,under laboratory conditions.cell cycle The term given to the series <strong>of</strong> tightly regulated steps that acell goes through between its creation and its division to form twodaughter cells.cell line Cells which grow and replicate continuously in cell cultureoutside the living organism.cel

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