RESULTS: Potency is an expression of the activity of a drug in terms of the concentration or amount of the drug required to produce a defined effect, whereas clinical efficacy judges the therapeutic effectiveness of the drug in humans. The differing methods of evaluating the activity of antihistamines in vitro and in vivo can lead to inconsistent results, which complicate the use of potency to predict clinical efficacy. Further, as therapeutic behavior is modulated by pharmacokinetic and pharmacodynamic parameters and by further interactions at sites other than the target receptor, it does not necessarily follow that more potent drugs have greater clinical efficacy.
CONCLUSIONS: Although potency can be a good preclinical marker of the therapeutic potential of a drug, clinical efficacy should only be evaluated within the patient population using appropriate outcome measures.