AAPS presents workshop on macromolecules

ALEXANDRIA, Va. - The American Association of Pharmaceutical Scientists (AAPS) will present the AAPS Workshop on Bioanalytical Methods Validation (BMV) for Macromolecules on March 1-3, 2000 at the Crystal Gateway Marriott in Arlington, Va. The workshop is co-sponsored by the California Society of Separation Services (CaSS), FDA, Fdration Internationale Pharmaceutique (FIP), and U.S. Pharmacopeia (USP).

The goals and objectives of the workshop are to:

  • Determine industry and regulatory standards established for BMV in support of the estimation and characterization for macromolecules in drug development.
  • Evaluate special validation considerations for quantitative, macromolecule-detecting technologies that have emerged since 1990 including immunoassays, cell-based assays, antibody titers and their automation in the laboratory.
  • Address the strengths/limitations and advantages/disadvantages for current approaches including assay parameters such as activity, sensitivity and stability specific to the macromolecule intended for measurement and characterization.
  • Develop a workshop report regarding appropriate bioanalytical validation criteria and standardization of terminology for the above that can be used by regulatory agencies to draft new guidelines for the bioanalytical validation criteria for macromolecule quantitation and characterization.

For more information on this workshop, including a complete preliminary program, registration fees, and accommodations, visit AAPS Online at www.aaps.org/edumeet/macro/index.html .


Contact: Debbie Mierke
American Association of Pharmaceutical Scientists

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