Release Date: May 25, 2012
U.S. Food and Drug Administration (FDA)
This Notice is to inform potential applicants that the FDA is revising RFA-FD-12-020, Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability (U01)," to clarify the Detailed Description section of the FOA.
The following modification to this FOA is being made:
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Detailed Description
CURRENT LANGUAGE:
The following physicochemical properties should be investigated in the project study:
Globule/particle size distribution
Surface charge
Osmolality
pH
Viscosity
Dispersibility
The project will involve two stages:
1. In vitro study Formulations with different physicochemical properties are manufactured using a selected steroid and characterized in vitro. Drug release and stability tests are conducted to understand how differences in physicochemical properties may affect ocular bioavailability. Formulations with key physicochemical properties which demonstrate the greatest potential impact on ocular bioavailability are selected for testing in vivo.
2. In vivo study Formulations selected based on the results of the in vitro study are tested in an animal model. A pharmacokinetic study should be conducted by assessing the ocular distribution of the steroid in various eye tissues and organs at various time points. A clinical endpoint study may be conducted as an alternative or to supplement the results of the pharmacokinetic study.
NEW LANGUAGE:
The following physicochemical properties should be investigated in the project study:
Globule/particle size distribution
Surface charge
Osmolality
pH
Viscosity
Dispersibility
The project will involve two stages:
1. In vitro study Formulations with different physicochemical properties are manufactured using a selected steroid and characterized in vitro. Drug release and stability tests are conducted to understand how differences in physicochemical properties may affect ocular bioavailability. Formulations with key physicochemical properties which demonstrate the greatest potential impact on ocular bioavailability are selected for testing in vivo.
2. In vivo study Formulations selected based on the results of the in vitro study are tested in an animal model. A pharmacokinetic study should be conducted by assessing the ocular distribution of the steroid in various eye tissues and organs at various time points. A clinical endpoint study may be conducted as an alternative or to supplement the results of the pharmacokinetic study.
Test formulations should be Q1 and Q2 the same, or nearly Q1 and Q2 the same, as the reference product. Several different test products should be formulated by making changes in the manufacturing process of the test products (and not compositional changes). It is anticipated that 2 or 3 test formulations would be carried forth into the in vivo study. A marketed product or a well-characterized investigational formulation may be used as the reference product.
Please direct all inquiries to:
Lisa Ko
Grants Management Specialist
U.S. Food and Drug Administration
Office of Acquisition and Grants Services
5630 Fishers Lane Room 1096
Rockville, MD 20857
TEL: 301-827-5095
FAX: 301-827-1044
EMAIL: Lisa.Ko@fda.hhs.gov
and Human Services (HHS)
