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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

EMA Draft Guideline on Validation of Bioanalytical Methods


Newsletters

November 2009

Steering Committee Meeting Minutes

August 14, 2009
April 22, 2009
January 21, 2009
October 17, 2008
June 18, 2008
April 30, 2008
March 19, 2008
February 20, 2008

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)


To join the Bioanalytical Focus Group, click here.

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  Leadership

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



Chair-Elect
Mark E. Arnold, Ph.D.
Bristol-Myers Squibb, Inc.
Princeton, NJ UNITED STATES




Click here to fill out a focus group membership form.

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Particle Engineering for Orally Inhaled Drug Products
9/10/2010

AAPS Workshop on Advances and Opportunities in Drug Product Manufacturing
9/20/2010

Third Annual Nanotechnology Symposium
9/24/2010

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