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BioAssay Validation <1032>, <1033> and <1034>

Course Information:

Course Description:

Bioassays play an integral part in the development and product life cycle of nearly all biotechnology-derived products and vaccines. This interactive course teaches the fundamentals of bioassay practices and principles along with associated statistical concepts. Course topics support implementation of guidance outlined in USP chapters <1032>, <1033> and <1034>. In addition to broadly elaborated ideas on bioassay design, these chapters employ statistical perspectives in pursuit of fit-for-use bioassay analysis and validation. The discussion includes tools for statistical and assay design, analysis, and validation needed when developing and performing bioassays.

Who Should Attend:

This course is intended for individuals who design, analyze, or validate bioassays for various purposes including drug characterization, product release, or stability study. It will also add value for biologists and statisticians who need to better understand their counterparts’ contributions. A basic understanding of statistics is desirable.


I Day

Learning Objectives and Course Outline:

Learning Objectives
  • At the conclusion of this course, the participant should be able to:
  • Select and apply appropriate statistical approaches to bioassay practices
  • Explain fundamental concepts of assay design and development
  • Explain practical elements of data analysis
  • Describe fundamental concepts of bioassay validation including protocol design, strategies and parameters

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