• Section Affiliations
  • Analysis and Pharmaceutical Quality (APQ)
  • Biotechnology (BT)
• Home
• Mission Statement
• Short-Term Goals
• Long-Term Goals
• Ligand Binding Assay Bioanalytical Online Discussion
• 2007 AAPS Excellence in Ligand Binding Assays Award

1. discuss issues that impact the validation and application of nonchromatographic assays,
2. seek an industry consensus for Pre-study and In-study validation of nonchromatographic assays,
3. discuss the role of statistical design and analysis as a means for enhancing the reliability of nonchromatographic assays,
4. serve as a forum to discuss emerging nonchromatographic technologies and automation used in the bioanalysis of small molecules and biotechnology products, and
5. discuss issues concerning the validation and application of in vitro assays for the quantification of biomarkers.

Presentations

• Incurred Sample Reanalysis 2008 Meeting Summary Slides
• Incurred Sample Reanalysis 2008 Workshop Survey Results

• Introduction Historical Perspective. Objective and Scope of the Work for Bioanalytical IA Variance Assessment. Why is it Worthwhile? (PDF)
  Jean W. Lee, Ph.D., Amgen, Inc.
  
• Results of Pilot Dataset – and how this Led to the Design of a Larger Data Set (PDF)
  Bruno Boulanger, Ph.D., Eli Lilly and Company
  
• Preliminary Data from PQRI – The Lessons Learned and Where Do We Go From Here? (PDF)
  Mario L. Rocci, Jr., Ph.D., Prevalere Life Services
  

LBABFG Podcasts

LBABFG Newsletters

Information

• LBABFG Article, AAPS Newsmagazine, June 2005 (PDF)
• Immunogenicity Assay Expectations Survey Results (PDF)

To join the Ligand Binding Assay Bioanalytical Focus Group, click here.

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