Analysis Considerations Related to Parallelism of Bioassay Data

• Activity Number: 225
• Type: Topic Contributed
• Date/Time: Monday, August 2, 2010 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Kristi L. Griffiths*+ and Bhavin S. Parekh
• Companies: Eli Lilly and Company and Eli Lilly and Company
• Keywords: bioassay ; parallelism

Abstract

Throughout the course of product development, the bioassay method is used to analyze different types of samples. The most common use is to measure the potency of the molecule relative to a reference standard for situations such as lot release, stability at the long term storage condition, and experimental design samples. In addition, there may be an interest to analyze isolated impurities as well as samples that have been kept under storage conditions that speed up the degradation. However, these samples may not produce dose response curves that are similar to the reference standard. This produces the challenge of how to analyze these samples. This talk will discuss different situations of analysis, particularly in regard to parallelism, and discuss how there can be general applicability for screening of large and small molecule agonist/antagonist for specific therapeutic targets.