Award
Food and Drug Administration 5U01FD005443-10
Development of Real-Time and Accelerated Dissolution Methods for a Long-Acting Levonorgestrel Intrauterine System
Recipient
University of Connecticut Storrs
Award Amount
$115,000.00
Ceiling
$115,000.00
Awarded
August 28, 2024
Identifier
5U01FD005443-10
A federal grant awarded to develop and optimize dissolution testing methods for long-acting levonorgestrel intrauterine systems to support generic product development and regulatory approval.
Description
This project aims to investigate qualitatively and quantitatively inequivalent levonorgestrel intrauterine system formulations to understand the impact of pharmaceutical processing, formulation variations, and device structure on in vitro drug release characteristics. The goal is to facilitate bioequivalence recommendations for generic products through in vitro methods, reducing regulatory burden and clinical studies while ensuring safety and quality.