observational studies

THE ACTUAL USE TRIAL: A DESCRIPTION OF DESIGN PRINCIPLES AND METHODS

by D C Bradford, D L McCammon, B C Page, C A Richardson, K A Hunter
Bradford D C.et al. Principles of Actual Use Trials. SelfCare 2010;1(4):117-123

The actual use trial is a method for assessing safety of a prescription drug under conditions resembling non-prescription use. Thus, it is generally a key study in an application for the over-the-counter (OTC) switch of a drug in the U.S.

SAFETY CONCERNS WITH OVER THE COUNTER DRUGS: MIND THE EVIDENCE GAP?

by Stephen Mann
Mann S. Safety Concerns With Over The Counter Drugs: Mind the Evidence Gap? SelfCare 2015;6(1):10-14.