Building towards Statistically-Based Pharmaceutical Quality Standards (U01)
The goal of this project is to generate data and develop a statistical sampling and analysis strategy to aid FDA/CDER policy in drafting data-based guidance in support of the use of appropriate statistical tools and standards.
Specifically, the development of standards for statistical methods suitable for lot release which could be used to drive industry towards increased product and process understanding throughout the lifecycle of a product.
The project will provide data, sampling and data analysis approaches to inform for the agency and the human pharmaceutical industry to advance the development of risk- and science-based standards.
These projects could be split into subsets by product type, process type, manufacturing complexity and/or therapeutic index to facilitate understanding.
Specifically, the development of standards for statistical methods suitable for lot release which could be used to drive industry towards increased product and process understanding throughout the lifecycle of a product.
The project will provide data, sampling and data analysis approaches to inform for the agency and the human pharmaceutical industry to advance the development of risk- and science-based standards.
These projects could be split into subsets by product type, process type, manufacturing complexity and/or therapeutic index to facilitate understanding.
Who's Eligible
Obtain Full Opportunity Text:
Full Announcement of RFA-FD-16-003 on NIH Guide for Grants and Contracts
Additional Information of Eligibility:
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U. S. Organizations are eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
Full Opportunity Web Address:
Contact:
Agency Email Description:
Agency Email:
lisa.ko@fda.hhs.gov
Date Posted:
2015-07-31
Application Due Date:
2015-10-16
Archive Date:
2015-11-15
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