Bioequivalence of Topical Products: Elucidating the Thermodynamic and Functional Characteristics of Compositionally Different Topical Formulations (U01) — Food and Drug Administration funding opportunity
Food and Drug Administration · Federal agency

Bioequivalence of Topical Products: Elucidating the Thermodynamic and Functional Characteristics of Compositionally Different Topical Formulations (U01)

Generic drug products demonstrate BE to the (brand name) reference listed drug (RLD) and/or reference standard (RS) product by showing that they can deliver the same amount of the same drug to the site(s) of therapeutic...

76
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Award $0–$250k Deadline 3011 days ago Location Alabama Type grant Level Federal Closed posted Mar 21, 2018
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Funding amount: up to $250,000 (total pool ~$500,000).
  • Next deadline: May 21, 2018.
  • Issued by: Food and Drug Administration.
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How was this generated?

The “key facts” mode pulls structured fields directly from the official source posting (amount, deadline, eligibility tags). The AI mode adds a short plain-English narrative on top, generated from the same source. Always verify with the agency before applying.

AI-generated. Always verify with the official source.

Who can apply — at a glance

  • Eligible applicants: see the Eligibility tab for the criteria from the official announcement.
  • Where: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming, District of Columbia.
  • Award: $0–$250k. Total program pool: $500,000.
  • Matching funds: not required.
  • Deadline type: Fixed.

Compiled from the official listing's structured fields — always verify with the funder before applying.

About the funder

Food and Drug Administration is a federal-level funder.

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Award amount
$0–$250k
Deadline
3011 days ago
May 21, 2018
Total pool
$500k

About this opportunity

Generic drug products demonstrate BE to the (brand name) reference listed drug (RLD) and/or reference standard (RS) product by showing that they can deliver the same amount of the same drug to the site(s) of therapeutic action at the same rate and to the same extent as the RLD/RS drug product. The FDA has been researching the feasibility of alternative, scientifically valid methods, including in vitro approaches, to support an evaluation of BE for topical drug products. These research initiatives have supported the development of multiple draft product specific guidance's for several topical drug products which have included an in vitro option to demonstrate BE in cases where the prospective generic drug product is Q1/Q2 the same as the RLD product.These in vitro BE approaches include, but are not limited to, comprehensive characterization of the physical and structural properties of complex topical dosage forms, potentially including comparative performance testing by an in vitro release test (IVRT) and/or an in vitro permeation test (IVPT). In certain cases, in vitro approaches have been recommended in concert with in vivo pharmacokinetic (PK) studies to collectively support a demonstration of BE, but again, only in cases where the prospective generic drug product is Q1/Q2 the same as the RLD product. The constraint on Q1/Q2 sameness mitigates the risk of potential failure modes for BE and/or TE that may arise when the composition of the prospective generic drug product is not the same as that of the RLD product.These most importantly, efficient approaches to demonstrate BE for topical drug products are less resource and risk-intensive than those involving comparative clinical endpoint studies, and facilitate the availability of high-quality topical generic drug products. However, in situations where the prospective generic drug product is non-Q1/Q2 with respect to the RLD product, a comparative clinical endpoint BE study is still routinely relied upon to demonstrate BE.In order to advance FDAs mission to make high quality, safe and effective drug products available to the American public, while supporting innovation, it is essential to explore the potential utility of novel, efficient BE standards for prospective generic topical drug products that are non-Q1/Q2 the same as the RLD product. To support this goal, it is necessary to investigate the potential failure modes for BE and/or TE that may arise from differences in the composition of a topical formulation, and to develop approaches to characterize the influence of such compositional differences on dosage form attributes and performance in a manner that appropriately mitigates the risk of potentially relevant failure modes for BE and/or TE.ObjectiveThe objective of this work is to support the development of accurate, sensitive and reproducible methodologies to characterize the dynamic thermodynamic properties and other aspects of topical dosage forms that are critical to their performance, and that, when found to be similar between compositionally different formulations, mitigate the risk of potential failure modes for BE and/or TE.This research should improve scientific understanding of fundamental mechanistic and/or physical principles that explain how the composition of a topical formulation, which may change as the dosage form undergoes metamorphosis ( drying) on the skin, influences the thermodynamic activity of the drug (and of other components of the formulation), and how this modulates drug delivery into the skin.

Funding agency

Food and Drug Administration
Federal agency

Tags

Healthcare & Biotech Manufacturing Energy & Utilities Arts & Culture Education & Research Construction & Housing Transportation & Logistics
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Who can apply

Eligibility details aren't on file yet — check the agency source link in the Documents tab for the latest rules.

Geographic eligibility

  • Alabama
  • Alaska
  • Arizona
  • Arkansas
  • California
  • Colorado
  • Connecticut
  • Delaware
  • Florida
  • Georgia
  • Hawaii
  • Idaho
  • Illinois
  • Indiana
  • Iowa
  • Kansas
  • Kentucky
  • Louisiana
  • Maine
  • Maryland
  • Massachusetts
  • Michigan
  • Minnesota
  • Mississippi
  • Missouri
  • Montana
  • Nebraska
  • Nevada
  • New Hampshire
  • New Jersey
  • New Mexico
  • New York
  • North Carolina
  • North Dakota
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Vermont
  • Virginia
  • Washington
  • West Virginia
  • Wisconsin
  • Wyoming
  • District of Columbia

How to apply

We don't have application instructions on file yet — head straight to the official source.

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Source documents

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Canonical NOFO, application packet, and forms
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Citation details

Source systemgrants.gov
Source ID301998
PostedMar 21, 2018

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