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  Bioanalytical Focus Group

The Bioanalytical Focus Group has been in existence since 2000. The group focuses on chromatographic assays applied to quantitative and qualitative investigations of small and large molecules in biological matrices that support drug discovery and development. The modern bioanalytical laboratory utilizes a range of technologies and techniques which are constantly evolving. This focus group helps coordinate AAPS supported programming and resources for its membership to help educate and inform of these developments.

Some specific goals include:

  • Coordinate AAPS programming suggestions from the membership to help educate and discuss pertinent bioanalytical topics
  • Raise awareness of regulatory developments that apply to appropriate areas of bioanalysis
  • Discuss emerging technology developments and applications
  • Through web site developments offer information resources pertaining to current bioanalysis articles
  • Offer a communication link with focus group membership on bioanalysis topics

Steering Committee Meeting Minutes

June 18, 2008
April 30, 2008
March 19, 2008
February 20, 2008

Workshop Presentations

AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations


Publications

The AAPS Journal, Volume 9, Number 1 / March, 2007
To view this paper, you must be logged into AAPS Pharmaceutica.
Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays
C. T. Viswanathan1, Surendra Bansal2, Brian Booth3, Anthony J. DeStefano4, Mark J. Rose5, Jeffrey Sailstad6, Vinod P. Shah7, Jerome P. Skelly8 , Patrick G. Swann9 and Russell Weiner10

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Veterinary Medicine (CVM)

May 2001
BP
Guidance for Industry: Bioanalytical Method Validation

To join the Bioanalytical Focus Group, click here.

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  Leadership

Chair
Ajai K. Chaudhary, Ph.D
Eli Lilly & Company
Indianapolis, IN UNITED STATES



Chair-Elect
Steve Lowes, Ph.D.
Advion BioServices Inc.
Ithaca, NY UNITED STATES



Past Chair
Dr. Mark J. Rose
Amgen Inc.
Thousand Oaks, CA UNITED STATES



Steering Committee Member
Nicolas Angell, Ph.D
Amgen Inc
Thousand Oaks, CA UNITED STATES



Steering Committee Member
Dr. Mark E. Arnold
Bristol-Myers Squibb, Inc.
Princeton, NJ UNITED STATES



Steering Committee Member
Surendra K. Bansal, Ph.D.
Hoffmann-La Roche, Inc.
Nutley, NJ United States



Steering Committee Member
Brian P. Booth
FDA\CDER\OCPB
Rockville, MD UNITED STATES



Steering Committee Member
Anthony DeStefano, Ph.D.
US Pharmacopeia
Rockville, MD



Steering Committee Member
H. Thomas Karnes, Ph.D.
Virginia Commonwealth University
Richmond, VA UNITED STATES



Steering Committee Member
Dr. Patrick T. Vallano
Mylan Pharmaceuticals. Inc.
Morgantown, WV UNITED STATES




Click here to fill out a focus group membership form.

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  Upcoming Events

THE CODE AT THE ‘COAL FACE’
10/17/2008

3rd Annual CDER on CMC: 21st Century Pharmaceutical Manufacturing and Control Strategies - A Changing Paradigm
10/20/2008

Bio-International 2008
10/22/2008

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