Food and Drug Administration Federal Grants
Showing results 26-50 of 72 for Food and Drug Administration federal grants, government grants and loans. For detailed information on a Food and Drug Administration federal grant including eligibility requirements or financial assistance, click the title.The project purpose is to identify the key groups influencing use of generic drugs, to determine the informational needs of these groups regarding generic drugs, and to test and revise draft messages designed to address those needs. An important...
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The primary objective of original RFA-FD-14-011 (subtopic 2) is to develop pharmacometric modeling and simulation tools for generic drug substitutability evaluation and post marketing risk assessment. The goal is to develop pharmacometic approaches...
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The purpose of this project is to: Subtopic 1: conduct physiologically-based pharmacokinetic modeling (PBPK) to relate critical quality attributes to in vivo performance for bioequivalence (BE) evaluation; Subtopic 2: perform population...
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There is a lack of compendial or biorelevant in vitro drug release assays for long-acting periodontal dosage forms. These products include biodegradable microspheres, in situ forming implants and matrix tablets. The purpose of this study is to...
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There is a lack of compendial or biorelevant in vitro drug release assays for long-acting contraceptive intrauterine systems. The objective of this study is to investigate dissolution methods, both real time and accelerated conditions, for...
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The Food and Drug Administration's (FDA), Office of Regulatory Affairs (ORA), Office of Partnerships (OP), is announcing the availability of a Cooperative Agreement to be awarded under a Limited Competition. The estimated amount of funds available...
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The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) is announcing its intent to accept and consider a single source application for the award of a grant to the American Society of...
www.FederalGrantsWire.com/kidney-health-initiative...
Earlier exploratory CDER research projects showed that dissolution and/or solubility of a poorly soluble drug (furosemide was studied as the model drug) was higher in medium containing milk and baby formula than that in standard buffer medium. ...
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This project follows after earlier CDER research projects in which in vitro furosemide dissolution and/or solubility data were collected in various dissolution media such as simulated gastric and intestinal fluids. In two different studies with...
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The purpose of the proposed study is to better understand the extent of pediatric accumulation of low molecular weight (LMW) species that may be found in PEG 3350 products (e.g., ethylene and diethylene glycol) and of PEG 3350 metabolites. PEG 3350...
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The goal of this project is to develop a mathematical algorithm or model to integrate in vitro chemical and biological characterization data to determine the degree of sufficiency of in vitro chemical and biological characterization assays, with...
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The purpose of this project is to conduct a prospective PK/PD study in attention deficit hyperactivity disorder (ADHD) patients to link the PK profiles to the time-course of PD activity of methylphenidate extended release products in order to...
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The purpose of this study is to evaluate existing tools and to develop new methods to monitor the drug safety, efficacy, usage, and substitution patterns of model authorized generics in different therapeutic categories in comparison with those of...
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The purpose of this study is to rank order generic drugs based on therapeutic class with low generic substitution/acceptance rate and analyze factors affecting the generic substitution in each therapeutic class. The outcome of this study will help...
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Background: Survival after solid organ transplantation has increased substantially due in part to the broad clinical use of immunosuppressants. Immunosuppressive regimens typically include a combination of a calcineurin inhibitor (tacrolimus or...
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Background: Solid dispersion has been investigated extensively to enhance bioavailability through improving dissolution property of poorly water-soluble drugs. In spite of the great potential for enhancing bioavailability using solid dispersion,...
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Metered dose inhalers (MDIs) consist of a formulation, with active ingredient(s) and possibly excipients in a propellant contained in a pressurized canister, and are aerosolized using a valve fitted to an actuator. Dose counters/indicators are an...
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Parenteral iron injection products are used to treat anemia, particularly in patients with chronic kidney disease (CKD). There are a number of parenteral iron complex products available in North America: iron sucrose, sodium ferric gluconate, iron...
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Background: Metoprolol is a selective β1 receptor blocker used in treatment of several cardiovascular diseases, especially hypertension. Metoprolol is metabolized primarily by the cytochrome P450 isoform CYP2D6, which is subject to a genetic...
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Background: Survival after solid organ transplantation has increased substantially due in part to the broad clinical use of immunosuppressants. Immunosuppressive regimens typically include a combination of a calcineurin inhibitor (tacrolimus or...
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The Office of Medical Policy (OMP) provides CDER oversight and leadership in the development of medical policy, procedures, and policy initiatives pertaining to drug development, drug approval, bioresearch monitoring, human subject protection and...
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FDA's CTP is seeking to develop a cigarette tobacco reference products program that will require significant collaboration and research efforts with outside organizations. The selected organization(s) will develop tobacco reference products...
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The overall goal of FAO's Food Safety and Quality Unit (AGN is to improve systems of food safety and quality management, based on scientific principles, that lead to reduced foodborne illness and support fair and transparent trade thereby...
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This project follows after earlier CDER research projects in which in vitro furosemide dissolution and/or solubility data were collected in various dissolution media such as simulated gastric and intestinal fluids. In two different studies with...
www.FederalGrantsWire.com/predictive-methods-for-c...
The Food and Drug Administration announces its intention to accept and consider a single source application for award to the World Health Organization (WHO) for the Building Research Capacity in Global Tobacco Product Regulation Program. The...
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