288 - If we are to conduct comparative analysis (our product vs. marketed products from the same category) to support a claim to be presented to HCP, what are the standards that the study and resutls should meet for PAAB to consider it acceptable?
Jennifer Carroll last edited by
I need a bit more info to provide an answer. Please clarify the following two parameters: the nature of the comparisoni.e. therapeutic comparison relating to efficacy/safety, pharmacoeconomic comparison, retention, format availability, other non-clinical features (e.g. receptor affinity/potency, MOA, preference, cosmetic/sensory attributes), etcÂ…the nature of the sourcei.e. a survey, a published clinical trial, product monographs, third party data, etcÂ…