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USP Bioassay Workshop

August 13-14, 2008
USP Headquarters, Rockville, Maryland

Bioassays continue to play an essential role in drug development and in many phases of the pharmaceutical product lifecycle. This workshop will address USP General Chapters on the Design, Development, Analysis and Validation of Bioassays. The development, analysis, and validation of bioassays typically require teams of scientists, technicians and statisticians to move a bioassay from development to practice. The new USP chapters and this workshop will provide best-practice guidelines to facilitate this process. The workshop will also explore the role of bioassays in monographs, the transition from animal assays to cell based assays, and bioassays for potency and immunogenicity testing. This interactive event will not only provide guidance and information on bioassays, but will also provide an opportunity for vigorous discussion of the compendial proposals. Upon completion of this two-day program, participants should be able to:

  1. describe the proposed changes to USP General Chapter <111> Analysis of Bioassays;
  2. discuss the two new USP General Chapters <1032> Design and Development Bioassays and <1033> Validation of Bioassays;
  3. evaluate a new approach to the determination of linearity and similarity (parallelism);
  4. compare and contrast the USP and EP approaches to the analysis of bioassays; and
  5. list general requirements for changing from an animal-based assay to a cell based assay.
Download the agenda  (1.5MB).

Presentations

(posted on August 23, 2008)

Session I: Analysis of Bioassays
Session II: Design, Development and Validation of Bioassays
Session III: Bioassays in Practice
Session IV: Bioassays for Potency and Immunogenicity