USP's 3rd Annual Bioassay Workshop: Next Steps

USP's seminal guidance chapters on bioassay design, development and analysis were proposed in the Pharmacopeial Forum. As these comprehensive Chapters moved into the implementation stage, the 3rd Annual Bioassay Workshop represented USP's commitment to continue the stakeholder dialogue on standards in the area of biological potency determination.

Topics:

  • Re-implementation of USP's entire suite of bioassay guidance Chapters, as proposed in PF36(4)
  • Product and assay specific issues with special attention to assay transition
  • Exchange of ideas among peers as these key bioassay chapters move from the proposal stage to official text
  • Specific bioassay topics for future revisions on product-specific bioassays
  • Examination of issues regarding the replacement and/or modernization of existing assays in the compendium with state-of-the-art tests
  • Participation in a product-oriented session focused on assays for toxins and antitoxins, neutralization assays

When: August 11–12, 2010

Where: USP Headquarters; Rockville, MD, USA

Agenda: Final agenda 

Workshop Materials:

Presentations:

Participants:
Professionals working in or with:

  • Bioassay Practitioners
  • Biostatisticians
  • Bioassay Software Experts
  • Pharmaceutical Industry Professionals
  • Biopharmaceutical Industry Professionals
  • Biotechnology Industry Professionals