Case Study

Bridging Studies For 505(b)(2) Approval

Source: INC Research/inVentiv Health

The sponsor required assistance with a 505(b)(2) application for a well established compound where a different salt of the active ingredient has been proposed. There were no claims of the product being clinically better by this modification to the active ingredient.

INC Research/inVentiv Health performed a GAP analysis while looking into the literature and the available information at the sponsor side. INC Research/inVentiv Health developed then protocols for “Clinical bridging studies” while taking advantage of the known safety and efficacy data of the active ingredient to provide the client with the most efficient and expeditious route to market. There are a variety of scenarios where information that is not generated by an applicant can be useful to support a submission for drug approval under Section 505(b)(2) of the FDC Act.

INC Research/inVentiv Health reviewed the scope and the extent of the available information that had an impact on the bridging studies to be performed and submitted. Protocols were then developed to assess the comparative bioavailability in attempt to meet the standards for bioequivalence between the new formulation and the reference product in addition to a food effect study to ensure safety and efficacy was not compromised.