Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional

id: 351078
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opportunityNumber: FOR-FD-24-002
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opportunityTitle: Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
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revision: 0
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agencyDetails: {"code":"FDA","seed":"HHS-FDA","agencyName":"Food and Drug Administration","agencyCode":"HHS-FDA","topAgencyCode":"HHS"}
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owningAgencyCode: HHS-FDA
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cfdas: [{"id":415567,"opportunityId":351078,"cfdaNumber":"93.103","programTitle":"Food and Drug Administration Research"}]
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forecastDesc: <p>The objective of this research proposal is to develop physiologically based pharmacokinetic (PBPK) model-based mechanistic in vitro in vivo correlations (IVIVCs) for two major types of long acting injectables (LAIs) such as crystalline suspensions and polymer-based implants by considering their distinct characteristics. The goal of the project is to develop a bottom-up mechanistic PBPK model for these two LAI categories by accounting for the influence of critical formulation attributes of each LAI drug product type to predict its in vivo release mechanism. The model formulation parameters and relevant physiology should be informed with suitable in vitro and in vivo experiments. A suitable preclinical animal model can be used to validate the PBPK model based IVIVCs for both LAI suspensions and polymer based implants.</p> <p><br></p> <p><span style="color: black;">The use of PBPK modelling provides a unique opportunity to understand how the physicochemical properties of drug molecules/polymer, implant specific properties, critical formulation attributes, and physiology, among other things, influence the in vivo release mechanisms of LAI drug products and their disposition characteristics. Moreover, once developed, a mechanistic PBPK model can help to define the 'safe space' for critical formulation attributes relevant to the reference listed drug (RLD) product, explain sources of PK variability and extrapolate predictions to human subjects by leveraging animal model data and by accounting for species-specific physiological differences.</span></p>
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applicantTypes: [{"id":"23","description":"Small businesses"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"04","description":"Special district governments"},{"id":"00","description":"State governments"},{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"25","description":"Others (see text field entitled \"Additional Information on Eligibility\" for clarification)"},{"id":"22","description":"For profit organizations other than small businesses"},{"id":"01","description":"County governments"},{"id":"02","description":"City or township governments"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"},{"id":"20","description":"Private institutions of higher education"},{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"05","description":"Independent school districts"},{"id":"06","description":"Public and State controlled institutions of higher education"}]
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applicantEligibilityDesc: Independent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions
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fundingInstruments: [{"id":"CA","description":"Cooperative Agreement"}]
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fundingActivityCategories: [{"id":"FN","description":"Food and Nutrition"},{"id":"HL","description":"Health"},{"id":"ST","description":"Science and Technology and other Research and Development"}]
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awardCeiling: 300000
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costSharing: false
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lastUpdatedDate: Nov 21, 2023 11:55:49 AM EST
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status: forecasted
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