Resources for Sustained Release Product Development

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NIAID is committed to supporting the development of ISR and other sustained release strategies such as nanotechnology-based injectable delivery systems and devices such as implants and transdermal patches. To this end, NIAID has developed a definition for prevention sustained release and included responsive elements in its drug development FOAs for the Prevention Innovation and Integrated Preclinical Clinical Programs (see NIAID Funding Opportunities).

For the purposes of drug development FOAs and access to contract (Comprehensive Resources for HIV Microbicides and Biomedical Prevention, CRMP) resources, sustained release is defined as the development of products and drug delivery devices that provide o 30 days or more protection from HIV infection via a single dose or when delivered by a continuous delivery device. Support through NIAID contract mechanisms can be requested for the following types of activities: 1) critical IND-enabling safety studies conducted in compliance with Good Laboratory Practice (GLP), 2) manufacture of drug products and substances in compliance with current Good Manufacturing Practice (cGMP), 3) analytical assay development or method transfer, and 4) planning and implementation of critical pharmacokinetic or efficacy studies in non-human primate and humanized mouse models.