Federal grant · project grant (b)
Stability Study Protocol for 0.1% Estradiol Type a Medicated Article (estraqua?) - Research & Related Other Project Information: Section 7 Project Summary/abstract This Type a Stability Project Is Required by the Fda Center for Veterinary Medicine to Complete a Portion of the CMC Technical Section of the New Animal Drug Application. This Project Will Evaluate Stability of Inad 012-884 (type a Medicated Article, 0.1% Estradiol (estraqua®)) Under Ambient (25 ± 2 °C / 60 ± 5% RH) and Accelerated (40 ± 2 °C / 75 ± 5% RH) Conditions Over Several Months. Appearance, Estradiol Level, Particle Size Distribution and Loss Upon Drying Will Be Evaluated Over Time. the Proposed Inad Will Be Administered in Feed (at a Dosing Rate of 5 PPM) to American Eels (anguilla Rostrata) in a Recirculating Aquaculture System (ras). Information From This Stability Study Will Substantially Contribute to Full Fda Approval.
Committed
$250,000
Paid out
$175.0K
70%
Committed, not yet paid
$75.0K
30%
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