Contact
- Steven Walfish, Principal Science & Standards Liaison - Global Science and Standards Division, slw@usp.org
Interested in learning more about the work of this Expert Committee?
Download Roster Observe a Meeting
Upcoming Official Meetings
- October 1, 2019
- November 7-8, 2019
Past Meetings – Executive Summaries
Focus Areas
- Standards for General Chapters concerned with the statistical treatment of data
- Support to Expert Committees on issues relating to statistics and biostatistics
Expert Committee Charge
The General Chapters–Statistics Expert Committee is responsible for providing statistical and metrological support for other Expert Committees in their development and approval of monographs, general chapters, and reference materials.
Key Issues
- Collaboration with the Validation and Verification Expert Panel to develop statistical tools for lifecycle approach to analytical procedures and to develop a case study of lifecycle approach to validation
- Continue the work supporting the bioanalytical chapters
- Incorporate metrological concepts into the scope of the Expert Committee
- Extend statistical tools to include Bayesian methods
Subgroups and Expert Panels
- Statistics of validation
- Bioassay
- Content Uniformity with Large Sample Sizes
Ballot Results and Standards–Development
Historic Prospectus
- General Chapter Prospectus: <1099> Limit on Number of Large Deviations when Assessing Uniformity in Large Samples (posted 24–Feb–2017; deadline 24–Mar–2017)