Validation Approach of Bioassays using statistical Method - Part of PharmaLab 2015
Speakers
PROF DR EDWIN VAN DEN HEUVEL
University of Technology, Eindhooven
DR PIETA IJZERMAN-BOON
MSD, The Netherlands
Objectives
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.
Background
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.
Target Group
..Manufacturing process professionals
..QA/QC staff and regulatory personnel
..Clinical staff, pharmacologists and toxicologists
..Project Managers & outsourcing personnel
..Analytical chemists and biochemists
Programme
Introduction
Guidelines
Type of bioassays
Basic Statistics
Bioactivity (USP <111>, EP5.3)
Calculation
Combination
Test set-up
Statistics for validation (USP<1032>, <1033>, <1034>)
Accuracy
Precision
Sensitivity & Specificity
Linearity & Range
Limit of detection & quantitation
Robustness
Dr. Pieta Ijzerman-Boon und Prof. Edwin van den Heuvel
This course is part of the GMP Certification Programme "ECA Certified Biotech Manager" Learn more
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