Stability Study Protocol for 0.1% Estradiol Type A Medicated Article (Estraqua?)

Novaeel, Inc., Halifax NS

Investigators

Abstract

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.