Opportunity Information: Apply for RFA FD 14 008
Apply for RFA FD 14 008
- The Food Drug Administration in the health science and technology and other research and development sector is offering a public funding opportunity titled "Dissolution Methods for Semisolid Ocular Drug Products" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on Apr 7, 2014 and posted on Mar 31, 2014.
- Applicants must submit their applications by May 2, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $700,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $350,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses County governments City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled Additional Information on Eligibility for clarification) Independent school districts Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education State governments Special district governments Small businesses.
- Foreign Recipients
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Opportunity Summary:
The FDA grant opportunity titled "Dissolution Methods for Semisolid Ocular Drug Products" focuses on improving how bioequivalence is demonstrated for generic semisolid eye medicines, such as ointments or gels intended for topical ocular administration. In many generic drug approvals, dissolution (or drug release) testing is a standard expectation because it provides a controlled way to measure how a drug product releases its active ingredient over time. For semisolid dosage forms, in vitro release testing can be especially helpful because these products are sensitive to manufacturing choices that may subtly change performance, even when the ingredient list matches the reference product.
A key issue the FDA is trying to address here is that generic ocular semisolids are typically designed to be Q1/Q2 equivalent to the Reference Listed Drug (RLD), meaning they use the same inactive ingredients (Q1) in the same concentrations (Q2). Even with Q1/Q2 sameness, differences in manufacturing processes can still lead to meaningful physicochemical differences, such as changes in microstructure, viscosity/rheology, particle size distribution, drug solubility within the base, crystal form, or how the drug is dispersed. Those differences can potentially influence bioavailability and clinical performance. The grant is intended to support research that determines which dissolution or in vitro release methods are best at detecting those manufacturing-driven differences and, ideally, which methods are most informative for predicting in vivo behavior.
The project has three main objectives. First, investigators are expected to prepare multiple Q1/Q2 semisolid ocular formulations that match a selected reference product but are made under different manufacturing conditions. The reference can be a marketed ocular semisolid or an investigational formulation. The manufacturing variations are intentional and are meant to generate test products that are compositionally the same yet potentially different in performance due to process effects. Alongside formulation work, the opportunity calls for physicochemical characterization of these test formulations to identify critical quality attributes that could affect drug release and bioavailability.
Second, the project must conduct dissolution or release studies on the prepared formulations using various in vitro release methods. Before starting the experimental dissolution work, the researchers are expected to perform a structured review of existing dissolution and release methods used for semisolid products. This assessment is supposed to compare the advantages and disadvantages of each approach, including how well each method can (a) detect manufacturing differences, (b) predict in vivo performance, and (c) remain robust and reproducible. Based on the characterization results, the formulations showing the largest and most relevant physicochemical differences (particularly those expected to impact bioavailability) should be prioritized for dissolution testing. Method development is expected to reflect both drug substance and drug product properties as well as the physiological environment relevant to ocular drug release.
Third, the project must identify at least one dissolution or in vitro release method that can discriminate among the different semisolid formulations. In practical terms, this means the chosen method should be sensitive enough to distinguish products that differ due to manufacturing, while also being reliable and resistant to common sources of variability. The final analysis of the methods used in the study should again document strengths and weaknesses, with specific attention to discrimination power, relationship to in vivo performance, and robustness. The overall deliverable is evidence the FDA can use to develop or refine recommendations for evaluating bioequivalence of generic ocular semisolid drug products.
From an administrative standpoint, this opportunity (Funding Opportunity Number RFA-FD-14-008) was offered by the Food and Drug Administration under CFDA 93.103 as a cooperative agreement, indicating substantial FDA involvement or collaboration during the project. The total estimated funding was $700,000 with an expectation of up to 5 awards. Individual awards were projected in the $300,000 to $350,000 range, with no cost-sharing requirement. Eligible applicants were broad and included U.S. public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses), and various levels of government and tribal organizations; foreign recipients were also listed as eligible. The posting date was March 31, 2014, with an original and final closing date of May 2, 2014, and an archive date of June 1, 2014.
In short, the grant is aimed at building a scientific basis for choosing and standardizing dissolution or in vitro release testing approaches that can meaningfully evaluate whether Q1/Q2 ocular semisolid generics perform like their reference products, even when manufacturing differences create subtle but important changes in the product’s physicochemical behavior.
FAQs: Dissolution Methods for Semisolid Ocular Drug Products (FDA)
What is the purpose of the FDA grant opportunity "Dissolution Methods for Semisolid Ocular Drug Products"?
The opportunity supports research to improve how bioequivalence is demonstrated for generic semisolid eye drug products (for example, ointments or gels for topical ocular use). The main focus is identifying dissolution or in vitro release methods that can reliably detect performance-relevant differences among formulations and, ideally, help predict in vivo behavior.
What types of drug products does this funding opportunity focus on?
It focuses on semisolid ocular drug products intended for topical ocular administration, such as ocular ointments and gels.
Why is dissolution (or drug release) testing important for generic drug approvals?
Dissolution or release testing is commonly expected in generic drug development because it provides a controlled way to measure how a drug product releases its active ingredient over time. For semisolid dosage forms, in vitro release testing can be particularly useful because these products can be sensitive to manufacturing choices that may change performance even when the formulation ingredients match the reference product.
What does Q1/Q2 equivalence mean in this context?
Q1/Q2 equivalence refers to a generic product being designed to match the Reference Listed Drug (RLD) by using the same inactive ingredients (Q1) in the same concentrations (Q2).
If a generic ocular semisolid is Q1/Q2 equivalent to the RLD, why might it still perform differently?
Even with the same inactive ingredients at the same concentrations, manufacturing process differences can lead to meaningful physicochemical differences. Examples mentioned include microstructure changes, differences in viscosity/rheology, particle size distribution, drug solubility in the base, crystal form, or how the drug is dispersed. These differences can potentially affect bioavailability and clinical performance.
What scientific problem is the FDA trying to address through this grant?
The FDA is seeking evidence-based approaches to select and standardize dissolution or in vitro release methods that can detect manufacturing-driven differences among Q1/Q2 semisolid ocular formulations and clarify which methods are most informative for predicting in vivo performance.
What are the main objectives of the project described in the opportunity?
The project has three main objectives: (1) prepare multiple Q1/Q2 semisolid ocular formulations that match a selected reference product but are manufactured under different conditions, and characterize their physicochemical attributes; (2) conduct dissolution or in vitro release studies using various methods, after first performing a structured review of existing methods; and (3) identify at least one dissolution or in vitro release method that can discriminate among formulations that differ due to manufacturing while remaining robust and reproducible.
What kind of formulation work is expected under Objective 1?
Investigators are expected to prepare multiple semisolid ocular formulations that are Q1/Q2 equivalent to a selected reference product, but manufactured under different intentional manufacturing conditions. The goal is to generate products that are compositionally the same yet may differ in performance due to process effects.
What can be used as the reference product?
The reference can be a marketed ocular semisolid product or an investigational formulation.
Why does the project include physicochemical characterization of the formulations?
Physicochemical characterization is intended to identify critical quality attributes that could affect drug release and bioavailability, and to help determine which formulations show the largest and most relevant differences to prioritize for dissolution or release testing.
What types of physicochemical differences are specifically highlighted as important?
The opportunity highlights differences such as microstructure, viscosity/rheology, particle size distribution, drug solubility within the base, crystal form, and drug dispersion as examples of attributes that may differ due to manufacturing processes and influence performance.
What is required before conducting the experimental dissolution or release studies?
Before starting the experimental dissolution work, researchers are expected to perform a structured review of existing dissolution and in vitro release methods used for semisolid products and assess the advantages and disadvantages of each approach.
What criteria should the structured review compare across methods?
The review is expected to consider how well each method can (a) detect manufacturing differences, (b) predict in vivo performance, and (c) remain robust and reproducible.
How should formulations be selected for dissolution testing?
Based on the characterization results, formulations showing the largest and most relevant physicochemical differences, particularly those expected to impact bioavailability, should be prioritized for dissolution or release testing.
What does the opportunity mean by "method development" in this project?
Method development is expected to reflect drug substance and drug product properties as well as the physiological environment relevant to ocular drug release.
What does it mean for a dissolution or in vitro release method to "discriminate" among formulations?
A discriminating method is one that is sensitive enough to distinguish between semisolid formulations that are Q1/Q2 equivalent but differ due to manufacturing-driven physicochemical changes, while still being reliable and resistant to common sources of variability.
What is the intended deliverable or outcome for the FDA?
The intended deliverable is evidence the FDA can use to develop or refine recommendations for evaluating bioequivalence of generic ocular semisolid drug products, particularly where manufacturing differences may lead to subtle but meaningful performance changes.
What is the Funding Opportunity Number for this grant?
The Funding Opportunity Number is RFA-FD-14-008.
Which agency offered this opportunity and under what mechanism?
The opportunity was offered by the Food and Drug Administration (FDA) as a cooperative agreement, indicating substantial FDA involvement or collaboration during the project.
What CFDA number is associated with this opportunity?
The CFDA number listed is 93.103.
How much total funding was estimated for this opportunity?
The total estimated funding was $700,000.
How many awards were expected?
The opportunity indicated an expectation of up to 5 awards.
What was the projected funding range per award?
Individual awards were projected in the $300,000 to $350,000 range.
Was cost sharing required?
No cost-sharing requirement was stated.
Who was eligible to apply?
Eligible applicants were broad and included U.S. public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) organizations); for-profit organizations (including small businesses); and various levels of government, tribal organizations, and other eligible entities. Foreign recipients were also listed as eligible.
What were the key dates for the opportunity?
The posting date was March 31, 2014. The original and final closing date was May 2, 2014. The archive date was June 1, 2014.
What is the overall focus in plain terms?
The overall focus is to build a scientific basis for choosing dissolution or in vitro release tests that can meaningfully evaluate whether Q1/Q2 generic ocular semisolids perform like their reference products, even when manufacturing differences create subtle but important changes in physicochemical behavior.
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