Course No 200025
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PROF DR EDWIN VAN DEN HEUVEL
University of Technology, Eindhooven
DR PIETA IJZERMAN-BOON
MSD, The Netherlands
The number of biopharmaceutical products is increasing in the clinic and in the market. This requires the development of biological tests to fully evaluate the biological functionality and safety. For the validation of such bioassays several experiments must be performed to demonstrate that the method is capable of measuring the biological activity of test samples. To quantify the performance statistical methods form an indispensable tool.
This workshop will provide information on the types of experiments and the statistical analyses that may be performed to calculate the bioactivity and estimate the validation parameters of bioassays. The workshop will discuss the guidelines on analysis and validation and the methods will be illustrated with real cases on bioassays.
..Manufacturing process professionals
..QA/QC staff and regulatory personnel
..Clinical staff, pharmacologists and toxicologists
..Project Managers & outsourcing personnel
..Analytical chemists and biochemists
Type of bioassays
Bioactivity (USP <111>, EP5.3)
Statistics for validation (USP<1032>, <1033>, <1034>)
Sensitivity & Specificity
Linearity & Range
Limit of detection & quantitation
Dr. Pieta Ijzerman-Boon und Prof. Edwin van den Heuvel