2015–2020 General Chapters - Statistics Expert Committee Work Plan

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 9–10, 2017 face-to-face meeting at USP–U.S., Rockville

Past Meetings – Executive Summaries

Latest Updates

  • October 9–10, 2017 face-to-face meeting at USP–U.S., Rockville

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