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. 2003 Nov 22;327(7425):1222–1225. doi: 10.1136/bmj.327.7425.1222

Table 2.

How dose related, time related, and susceptibility related classifications of adverse drug reactions fulfil criteria for satisfactory classification

Classification
Criterion Dose related Time related Susceptibility related
Allows classification on basis of clinical features No; dose dependency is not always clear from clinical observations and dose ranging studies are not always available Yes; the time course of a reaction can be directly observed in individual cases or populations Sometimes, depending on type of susceptibility
Give insight into mechanism of reaction No; only implies the range of doses at which it occurs Yes; different mechanisms have different time courses Yes; mechanism and susceptibility are often linked
Avoids assigning a reaction to more than one category No Yes No; an adverse drug reaction may be associated with multiple susceptibility factors
Suggests how to monitor adverse reactions Yes Yes Yes
Suggests population strategies for pharmacovigilance Yes Yes; also tells the patient when to be alert for an adverse reaction Yes (can identify patients at high risk or low risk)
Helps in making decisions on treatment or avoiding adverse reactions Only some types Yes Only some types
Guides drug development and regulation Yes; can help in defining the therapeutic dosage range Yes; suggests strategies for monitoring during drug development and after marketing Yes; defines subgroups at high risk or low risk