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  Ligand Binding Assay Bioanalytical Focus Group

This group focuses on technologies and issues pertaining to the bioanalysis of analytes by nonchromatographic assays, including binding assays, immunoassays, activity- and cell-based assays. Some specific goals are to:
  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

November 2007: Variability of Ligand Binding Assays Used for PK Protein Drug Bioanalysis – Database Collected as a Follow-up to the 2006 AAPS Crystal City III Workshop


LBABFG Podcasts

As part of our effort to enhance communication with our members, the LBABFG steering committee announces the establishment of audio podcast recordings. It is an MP3 recording and should play in any media player on your computer.

Podcast #1, January 2007 (MP3)

LBABFG Newsletters

October 2008 (PDF)
July 2008 (PDF)
April 2008 (PDF)
January 2008 (PDF)
September 2007 (PDF)
April 2007 (PDF)
January 2007 (PDF)

Information


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

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  Leadership

Chair
Bonita J. Rup, Ph.D.
Wyeth Research
Andover, MA United States



Chair-Elect
Jean W. Lee, Ph.D.
Amgen Inc.
Thousand Oaks, CA UNITED STATES



Past Chair
Dr. Steven J. Swanson
Amgen
Thousand Oaks, CA UNITED STATES




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ACS/AAPS Formulation Development and Drug Delivery Systems Short Course
12/4/2008

Pharmaceutical and Biomedical Analysis Symposium
3/1/2009

Strategic Management of CMC Dossiers in the eCTD Format: What CMC Professionals Need to Know Now!
3/10/2009

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