Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) (RFA FD 18 018)
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on May 23, 2018.
- Applicants must submit their applications by Jun 20, 2018 RFA was posted on 04/20/2018 - due to a an error it was posted as RFD-FD-18-018. This is a correction on the title of the RFA.
- Each selected applicant is eligible to receive up to $1,800,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: State governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, Others (see text field entitled Additional Information on Eligibility for clarification).
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|Funding Number||Funding Title|
|RFA FD 18 024||Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01)|
|PAR 18 827||Minor Use Minor Species Development of Drugs (R01)|
|RFI NOT FD 18 014||Request for Information (RFI): FDA Standard Core Clinical Outcome Assessments and Endpoints|
|RFA FD 19 002||Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed)|
|RFA FD 19 005||Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional|
|RFA FD 19 014||Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required) Activity Code|
|RFA FD 19 008||Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed)|
|RFA FD 19 009||Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required)|
|RFA FD 19 010||Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed)|
|RFA FD 19 003||Cooperative Agreement to Support the Illinois Institute of Technology's Institute for Food Safety and Health (U19 Clinical Trial Optional)|
|RFA FD 19 011||Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) - Clinical Trials Optional|
|PAR 19 190||Advancing Post-Market Surveillance of High-Risk Facilities and Products through Signal detection, Data analysis, and the Review of the State of Quality (U01) Clinical Trial Optional|
|PAR 19 216||Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional|
|RFA FD 19 021||Implementation of the Animal Feed Regulatory Program Standards (U18 Clinical Trial Not Allowed)|
|RFA FD 19 018||Maintenance and Enhancement of ISO/IEC 17025 Accreditation and Whole Genome Sequencing for State Food Testing Laboratories (U18 Clinical Trial Not Allowed)|
|RFA FD 19 020||Novel Approaches to Translational Evidence Generation to Advance Coordinated Registry Networks (CRNs) via Big Data Analytics Using Disparate Data Sources (U01 Clinical Trial Optional)|
|RFA FD 19 019||Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01 Clinical Trial Not Allowed)|
|RFA FD 19 015||Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trial Required|
|RFA FD 19 013||Convener and organizer of activities and engagements focused on the development of medical products and related processes, surveillance, and policies relevant to ongoing public health activities. (U01) Clinical Trial Not Allowed|
|RFA FD 19 016||Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional|
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