FDA funding for various new studies/technologies to evaluate generic drug equivalence
Contributor: Sherry Ward, AltTox
The FDA has released a number of new funding opportunities, some with the potential for development or use of human clinical and/or in vitro methodologies.
Part of one of the funding announcements is shown below. The full list of funding announcements is provided on this webpage: FY2016 GDUFA Regulatory Science Funding Announcements.
The purpose of this funding opportunity is to support the research and development necessary to advance spectroscopic imaging technologies, methods, study designs, and analyses to non-invasively measure the rate and extent to which a topically applied compound becomes available in the epidermis, at or near a site of action within the skin. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that measures the amount of drug present in the epidermis at each of a series of depths below the skin surface, which can be utilized to monitor epidermal pharmacokinetics by repeated measurements over time.
The intent is that the technology developed under this cooperative agreement with the FDA will demonstrate how the epidermal bioavailability of a drug can be characterized by imaging measurements across time, which would quantify the amount of drug at relevant depths in the epidermis as it changes over time. The ultimate purpose of the funding opportunity is to complete proof-of-principle in vitro and/or in vivo studies using imaging technology to characterize that the bioavailability of a topically administered drug is the same from treatments that are expected to be bioequivalent (e.g., a U.S. marketed generic product vs. its reference listed drug product), and is discriminated as not being the same from treatments that are not expected to be bioequivalent.
The rationale for offering the funding opportunity as a multi-year award is to afford sufficient time and resources to research and develop the imaging technology and methodologies, and to conduct multiple in vitro and/or in vivo studies with multiple drugs and drug products selected in collaboration with the FDA, including drug products for which comparative clinical endpoint bioequivalence studies have been completed, and in each case involving treatments that represent positive and negative controls for bioequivalence. The intent of the cooperative agreement is that the award recipient will work collaboratively with FDA scientists to refine the research strategy, develop study designs and protocols, orchestrate study conduct and publish the results.