Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

NOVEL METHODOLOGIES AND IVIVC APPROACHES TO ASSESS BIOEQUIVALENCE OF TOPICAL DRUG

Award Number: U01FD004946
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2013
PERIOD OF PERFORMANCE END DATE: 12/31/2015

Group Awards By:

View Award Description

NOVEL METHODOLOGIES AND IVIVC APPROACHES TO ASSESS BIOEQUIVALENCE OF TOPICAL DRUG - Generic drugs now represent the major part of the US pharmaceutical market. They are an attractive alternative to brand products for consumers because they are bioequivalent and therefore the same in terms of quality, safety and efficacy, but available at a considerably reduced cost. However, there are still products for which no or few generic alternatives are available. A big barrier to generic drug development is that the sponsor must demonstrate that their product is bioequivalent to the reference-listed drug (RLD). This is a particular challenge for the development of dermatological drugs because these drugs act locally, whereas most tests for bioequivalence (BE) use blood measurements. Thus, manufacturers must rely on clinical endpoint studies, which are not only expensive and time consuming, but also rather unreliable. Hence, there is an urgent need for new, more efficient ways to demonstrate BE of topical drugs. In particular, in vitro methods that correlate well with the in vivo situation would significantly facilitate the development of topical generic drugs. We will investigate in vitro and in vivo methods to show BE of topical products and will establish in vitro - in vivo correlations (IVIVC) at the level of pharmacokinetics in the dermis. First, we will conduct a clinical study to assess BE and non-BE in skin using dermal open flow microperfusion (dOFM) according to GCP and GLP. The results will serve as a "gold standard" for the in vivo situation in the dermis, and as a reference for validating all present and future in vitro methods for their ability to predict the in vivo situation. Secondly, we will examine in vitro methods to establish BE, starting with the only FDA- accepted in vitro approach as per the "FDA Draft Guidance on Acyclovir". We will then investigate innovative in vitro systems based on dOFM as a new in vitro approach for BE. We will use Zovirax 5% ointment (RLD) to demonstrate BE and Zovirax 5% creme to demonstrate non-BE against Zovirax 5% ointment. The same formulations will be used to demonstrate BE and non-BE in all in vitro and in vivo systems. All experiments will be performed under quality-controlled standards (ISO 9001, GCP, GLP. EN ISO 13485). One analytical HPLC-MS/MS method suitable for all project samples will be developed and validated according to ICH guidelines in a GLP-certified laboratory. All results of the BE and non-BE pairs using different methods will be analyzed for their predictive power. By cross- referencing the results, we plan to correlate in vitro with in vivo data to establish IVIVC.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2018 ( Subtotal = $0 )
2018	2014	JOANNEUM RESEARCH FORSCHUNGSGESELLSCHAFT MBH	LEONHARDSTRASSE 59	GRAZ	STEIERMARK	8010		AUT	Food and Drug Administration Research	000	2	12/5/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2014 ( Subtotal = $250,000 )
2014	2014	Joanneum Research	Elisabethstrasse 5	Graz				AUT	Food and Drug Administration Research	001	2	9/9/2014	NON-COMPETING CONTINUATION	$250,000
														Subtotal = $250,000

Grand Total All Awards = $250,000

Top

All Categories

About

Search

Reports

Data Submission

Award Information

NOVEL METHODOLOGIES AND IVIVC APPROACHES TO ASSESS BIOEQUIVALENCE OF TOPICAL DRUG

Award Number: U01FD004946

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/15/2013

PERIOD OF PERFORMANCE END DATE: 12/31/2015

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer