Building towards Statistically-Based Pharmaceutical Quality Standards (U01)
Sector: Commercial • Location: United States of America
Source: Grants.gov
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 unde
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Participants
Sponsoring Agency | Obfuscated Data |
Company | Obfuscated Data |
Status
Original status | archived |
Taiyo status | Obfuscated Data |
Taiyo last update | 00-00-0000 |
Available timestamps | 00-00-0000 |
Available timestamp type | Obfuscated Data |
Contact
Contact name | Obfuscated Data |
Phone | 0000000000 |
ObfuscatedData@email.com | |
Address | Obfuscated Data, Obfuscated data, obfuscated data, Obfuscated data |
Description
Description | 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. |
Original sub-sector | Obfuscated |
Original Currency | USD |
Original budget | 000000000000000 |
Procurement method | Obfuscated Data |
Budget | 000000000000000 |
Location
Region | Obfuscated |
Country | Obfuscated |
State | Obfuscated Data |
County | Obfuscated |
Location | Obfuscated Data, Obfuscated data, obfuscated data, Obfuscated data |
Source
Source reliability | High |
Data quality score | 100% |
Source | Obfuscated Data |
URL | obfuscated_data,obfuscateddata.com |
More Details
Project Type | Obfuscated Data |
Article Published Date | Obfuscated Data |