Pharmacometric Modeling and Simulation for Generic Drugs Evaluation

The summary for the Pharmacometric Modeling and Simulation for Generic Drugs Evaluation grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Food Drug Administration, which is the U.S. government agency offering this grant.
Pharmacometric Modeling and Simulation for Generic Drugs Evaluation: Computational modeling and simulation is one of the priority areas of Fiscal Year 14 GDUFA (Generic Drug User Fee Act) Regulatory Research program. It is essential to developing a modern ANDA (Abbreviated New Drug Application) review process that fully utilizes available computational and analytical tools. The focus of this FOA/RFA is to utilize pharmacometric modeling and simulation and develop quantitative methodology for generic drugs evaluation in several areas. Objectives: The objectives of this project are to develop quantitative models for generic drugs evaluation in the following areas: 1. Population pharmacokinetic and pharmacodynamic, dose-efficacy, and dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs. The goal is to develop models and modeling approaches that will help FDA classify drugs as having a narrow therapeutic index and identify those products that have a clinical use profile that requires tighter control of product quality and equivalence attributes. 2. Pharmacometric modeling and simulation for generic drug substitutability evaluation and post marketing risk assessment. The goal is to develop pharmacometic approaches (including clinical trial simulation and clinical use/substitution simulation) that will aid OGD in the evaluation of post-market risk and the interpretation of post-market adverse event reports or product substitution complaints. 3. Pharmacometric modeling and simulation for partial AUC (area under the concentration vs. time curve) as bioequivalence criteria. The goal is to develop modeling and simulation tools that will aid FDA in identifying which generic drug products require greater degrees of pharmacokinetic profile similarity in order to assure therapeutic equivalence. Detailed Description: Applicants who wish to apply for more than one subtopic should submit separate proposals for each subtopic as listed below: Subtopic 1: Population pharmacokinetic and pharmacodynamic, dose-efficacy, and dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs. The objective of this subtopic is to develop population pharmacokinetic and pharmacodynamic, dose-efficacy, and dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs. The quantitative model will be used to (1) define whether the drug candidate is belonged to NTI drugs, and (2) evaluate bioequivalence criteria for NTI drugs. Subtopic 2: Pharmacometric modeling and simulation for generic drug substitutability evaluation and post marketing risk assessment. The objective of this subtopic is to develop pharmacometric modeling and simulation methodology to evaluate generic substitutability to address concerns about generic drug substitutability and for post marketing risk assessment. The suggested model drug products include but are not limited to antiepileptic drugs, attention deficit hyperactivity disorder drugs, and antidepressants. Subtopic 3: Pharmacometric modeling and simulation for partial AUCs (area under the concentration vs. time curve) as bioequivalence criteria. The objective of this subtopic is to develop pharmacometric modeling and simulation methodology to evaluate partial AUCs as bioequivalence criteria. Some examples of specific questions to answer are (1) whether partial AUCs are needed for these drug products, (2) what are the appropriate partial AUCs for evaluation of bioequivalence.
Federal Grant Title: Pharmacometric Modeling and Simulation for Generic Drugs Evaluation
Federal Agency Name: Food Drug Administration
Grant Categories: Health Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: RFA-FD-14-011
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.103
CFDA Descriptions: Food and Drug Administration_Research
Current Application Deadline: Jun 2, 2014
Original Application Deadline: Jun 2, 2014
Posted Date: Mar 28, 2014
Creation Date: Mar 28, 2014
Archive Date: Jul 2, 2014
Total Program Funding: $2,500,000
Maximum Federal Grant Award: $250,000
Minimum Federal Grant Award: $150,000
Expected Number of Awards: 7
Cost Sharing or Matching: No
Applicants Eligible for this Grant
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Small businesses
Native American tribal organizations (other than Federally recognized tribal governments)
For profit organizations other than small businesses
City or township governments
Public and State controlled institutions of higher education
Independent school districts
Private institutions of higher education
State governments
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Special district governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
County governments
Native American tribal governments (Federally recognized)
Additional Information on Eligibility
Foreign Institutions
Link to Full Grant Announcement
NIH Guide for Grants and Contracts
Grant Announcement Contact
Gladys Melendez-Bohler Grants Management Specialist Phone 301-827-7175
FDA Office

Food & Drug Administration 301-443-5869
Similar Government Grants
Development and Maintenance of the Animal Food Regulatory Program Standards (U19) Clinical...
Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biologic...
Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade ...
Cooperative Agreement for Long Term Data Collection on Antimicrobial Use in Animals (U01) ...
Alliance to Support the Activities of the Integrated Food Safety System (IFSS), including ...
Support for Small Scientific Conference Grant Program
Cooperative Agreement to Support the World Health Organization (WHO) International Program...
Clinical Studies of Safety and Effectiveness of Orphan Products
More Grants from the Food Drug Administration
NARMS Cooperative Agreement Program to Enhance and Strengthen Antibiotic Resistance Survei...
Cooperative Agreement to Support Shellfish Safety Assistance Project (U01)
Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA C...
Local Food Producer Outreach, Education, and Training to Enhance Food Safety and FDA Food ...
National Training, Education, Extension, Outreach, and Technical Assistance Competitive Gr...

FederalGrants.com is not endorsed by, or affiliated with, any government agency. Copyright ©2007-2024 FederalGrants.com