This bioassay course will focus on factors to be considered in the design, development and validation of bioassays. The course introduces related USP general chapters, terminology, bioassay life cycle, important statistical tools and best practices, followed by a detailed discussion on the topics of design and development, robustness, validation and post-validation, with examples of USP pharmacopeial bioassays. The course reflects statistical tools in USP General Chapters <111>, <1030>, <1032>, <1033> and <1034>.
Subject area:
Biologics
Objectives (If applicable):
• Understand the structure of USP bioassay general chapters
• Recognize applicable terminology
• Explain concepts of relative potency
• Understand the bioassay life cycle
• Identify important tools and prerequisites
• Recognize bioassay best practices
• Explain bioassay design and development:
o Fitness for use/potential challenges
o Screening and optimization
o Number and spacing of standards for the curve
o Replication, uniformity, outlier detection, optimization, experimental design concepts and randomization
o Data and assumptions, variance heterogeneity
o Goodness for fit and measurement of uncertainty
o Normality, transformation and weighting
o Validity/assay/system/sample suitability criteria
o Acceptance criteria
• Understand robustness (experimental design concepts)
• Explain bioassay validation and post-validation:
o Identifying and measuring significant sources of error
o Experimental design and acceptance criteria
o Statistical considerations involved
• Provide examples of USP pharmacopeial bioassays
Target Audience (If applicable):
This course is designed for professionals who perform, supervise, manage, audit or oversee the development and validation of bioanalytical assays.
This course is designed for attendees with a minimum of three (3) years of bioassay experience; five (5) years is recommended.