Validation Approach of Bioassays using statistical Methods (Workshop)

Objectives

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.

Background

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.

Target Audience

• Manufacturing process professionals
• QA/QC staff and regulatory personnel
• Clinical staff, pharmacologists and toxicologists
• Project Managers & outsourcing personnel
• Analytical chemists and biochemists

Programme

7 November, 09.00 – 18.00 h

Module 1: General Part

• Introduction
• Guidelines
• Statistics

Module 2: Bioactivity (USP <111>, <1034>, EP5.3)

• Calculation
• Similarity
• Combination

8 November, 09.00 – 16.00 h

Module 3: Development (USP <1032>)

• Assay design
• Assay criteria

Module 4: Validation (USP <1033>)

• Precision & Accuracy
• Linearity
• Range
• Specificity
• Summary

Moderation

Prof. Edwin van den Heuvel, University of Technology, Eindhoven, The Netherlands

Speakers

Prof. Edwin van den Heuvel, University of Technology, Eindhoven, The Netherlands
Professor at the TU/e department of Mathematics and Computer Science; professor Medical Statistics at the UMCG (University Medical Center Groningen).

Pieta IJzerman, Boon, MSD, the Netherlands
Associate Director Quantitative Sciences/Center for Mathematical Sciences-Europe