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Human Respiratory Epithelial Tissue Models for Opioid-Reversal Nasal Spray Perme

Forecast
Federal

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The Food and Drug Administration is seeking a provider for specialized human-derived nasal and respiratory epithelial tissue models and corresponding culture media. These materials are essential for an FDA-funded project focused on the in vitro characterization of generic drug products used for opioid overdose reversal, specifically testing the permeation of naloxone and nalmefene nasal sprays across physiologically relevant barriers. The acquired tissues will be used to generate biorelevant data to evaluate how different formulations affect drug absorption and to support the development of alternative in vitro approaches for non-Q1/Q2 generic products. Funding for these batch orders of 3D human-derived respiratory epithelial tissue models has been specifically allocated within the project's awarded proposal to facilitate these critical permeation studies.

General Info

FDA seeks human respiratory tissue models and media for opioid overdose drug testing.

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

USA

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration
Contacts2 people available
OfficeN/A
Office AddressN/A
Contacts
Cder Acquisition Liaison
To Be Determined To Be DeterminedContracting Officer

Full Description

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This contract will provide specialized human-derived nasal and respiratory epithelial tissue models and associated culture media required for the FDA-funded project "In Vitro Characterization to Support Development and Approval of Generic Drug Products for Opioid Overdose Reversal" under opioids research awards. The tissues will be used to test permeation of naloxone and nalmefene nasal spray products across physiologically relevant epithelial barriers, generating biorelevant in vitro data to evaluate formulation-dependent drug absorption and support development of alternative in vitro approaches for non-Q1/Q2 generic opioid-overdose reversal products. The purchase is specifically anticipated in the awarded proposal, which allocates project funds for batch orders of 3D human-derived respiratory epithelial tissue models needed for the permeation studies.

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