On the Reporting of Adverse Drug Events

摘要: In this paper only dose dependent adverse drug events will be discussed. Adverse are by definition a problem in efficacy studies. studies of anti-epileptic drugs an additional arises. As the desired effect is suppression paroxysmal and unpredictable event, titration to reach optimal not readily practicable using parameter. It commonly accepted substitute occurrence effects as endpoint minus one for phase. Of course poses with respect reporting side effects. Proper policy would disregard side-effects elicited during The possibility monitor serumlevels did offer way out choosing serumlevel below "toxic range" first end-point titration. However, recent show little or no correlation between pharmacodynamic properties these drugs. Examples vigabatrin milacemide. If reported steady state relation seizure whimsical nature may become confounding factor. was shown epileptologists from Milani mayor disappear spontaneously. There systematic about pathophysiology tolerance phenomenon. there anecdotal reports people withdrawn treatment who felt much improved even though they have any formal complaints prior withdrawal. drug-trial methods section often contains information procedures evaluation events. For example Reynolds et al. 2 on study it stated that "Efficacy assessed