Course Description:This three-day bioassay course consists of a two-day lecture presentation and a one-day hands-on laboratory experience. It will focus on the essential 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 bioassay. The course reflects statistical tools in USP General Chapters <111>, <1030>, <1032>, <1033> and <1034>.
The lab portion of the course introduces attendees to best practices and techniques for successful bioassay development and validation.
By taking this course, you will be able to:
- 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:
- Fitness for use/potential challenges
- Screening and optimization
- Number and spacing of standards for the curve
- Replication, uniformity, outlier detection, optimization, experimental design concepts and randomization
- Data and assumptions, variance heterogeneity
- Goodness for fit and measurement of uncertainty
- Normality, transformation and weighting
- Validity/assay/system/sample suitability criteria
- Acceptance criteria
- Understand robustness (experimental design concepts)
- Explain bioassay validation and post-validation:
- Identifying and measuring significant sources of error
- Experimental design and acceptance criteria
- Statistical considerations involved
- Provide examples of USP pharmacopeial bioassays
- Demonstrate your experience using bioassay tools in the laboratory
Who Should Participate:This course is designed for professionals who perform, supervise or manage design, development, analysis and validation of in vitro bioassay/potency assays.
This course is designed for attendees with a minimum of three (3) years of bioassay lab experience; five (5) years is recommended.