Challenges, Prechallenges, Dechallenges And Rechallenges

By Bart Cobert

This is an interesting topic for which several confusing points have arisen and which merits an in depth look.

These concepts are frequently used in the discussion of causality and regulatory agencies pay particular attention to them in assessing individual case safety reports particularly in the post-marketing setting.

Challenge – In our pharmacovigilance world, this refers to the giving of the drug to the patient during the AE or treatment in question. That is, a patient is started today on, say, ampicillin orally. This is the “challenge”.