Opportunity Information: Apply for RFA FD 14 024
The government grant opportunity titled "Pharmacokinetic and Pharmacodynamic (PK PD) Studies of Cardiovascular Drugs (U01)" aims to address concerns regarding the bioequivalence and therapeutic equivalence of metoprolol, a selective beta-1 receptor blocker commonly used to treat cardiovascular diseases such as hypertension. Metoprolol is primarily metabolized by the CYP2D6 enzyme, which varies among individuals due to genetic differences. Variations in the drug's formulations—such as salt forms and dosage types—can lead to differing pharmacokinetic (PK) profiles and potential therapeutic effectiveness.
The FDA has observed issues when patients switch from brand-name to generic metoprolol, including reports of ineffectiveness and adverse events. As the agency has not reached definitive conclusions on these concerns, there is a pressing need for PK/PD studies in patients to elucidate the intricacies of metoprolol's performance.
The objectives of the proposed study are to conduct a prospective PK/PD analysis involving hypertensive patients to establish relationships between drug pharmacokinetics and its pharmacodynamic effects. Key study goals include evaluating the PK/PD relationship, assessing the impact of treatment changes (specifically switching metoprolol products), analyzing variations in pH and delivery rates, and understanding the influence of CYP2D6 genetic variations.
A randomized crossover trial design is recommended, allowing for patients to switch products while maintaining the same dosage. This study will simultaneously collect PK and PD samples to connect PK characteristics with their effects on patients. The research will also focus on enrolling both extensive and poor CYP2D6 metabolizers to better understand how genetic differences affect drug metabolism and efficacy.
In the first year, efforts will concentrate on developing a study protocol for necessary approvals, ensuring product blinding, quality testing, validating bioanalytical methods, and initiating patient enrollment.Apply for RFA FD 14 024
- The Food Drug Administration in the health science and technology and other research and development sector is offering a public funding opportunity titled "Pharmacokinetic and Pharmacodynamic (PK PD) Studies of Cardiovascular Drugs (U01)" 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 18, 2014 and posted on Apr 18, 2014.
- Applicants must submit their applications by Jun 2, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2025.)
- The funding agency has allocated a total of $3,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Public and State controlled institutions of higher education Small businesses For profit organizations other than small businesses State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) County governments Independent school districts Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities Private institutions of higher education.
- Foreign Recipients
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