This course will introduce the statistical concepts needed for bioassays (all illustrated with useful and relevant examples), review properties of bioassays, and show how the statistical methods apply to bioassay. To work with the practical constraints in the laboratory the statistical methods must adapt. Using design of experiments (DOE) for bioassay development, validation, and monitoring is powerful and effective when informed by these constraints and adaptations. Examples (mostly from cell-based bioassays; some using robotics) will illustrate strategic ways to design bioassays to make it (relatively) easy to apply DOE in early bioassay development when measuring the capability of a bioassay, when improving an existing bioassay, and when doing validation. We will cover ways that these strategic assay design considerations, when combined with good assay analysis methods, also support good assay monitoring with graphical and quantitative tools as part of a lifecycle approach.
TOPICS TO BE COVERED INCLUDE:
- Statistical concepts
- Biological assays
- Fundamental concepts
- Types of bioassays
- Similarity: what, why, and how
- Properties of bioassays
- Introduction to ‘Classical’ Design of Experiments
- Factorials: why and how
- Blocking and other designs
- Sequences of experiments Using DOE with bioassays
- Bioassay analysis
- Challenges: non-constant variance, non-normality, outliers
- Modeling methods: non-parametric, linear, nonlinear
- Mixed models: what, why, and how
- Similarity and Potency Considerations when setting product specifications
- Clinical experience
- Manufacturing experience
- Assay and process capability
- Setting assay and sample acceptance limits in bioassays
- Modular assay designs ease development, robustness, qualification, and validation
- Qualification and validation design and analysis
- Assay monitoring
- Managing changes in assays
- Assay transfers
- Assay updates
WHO SHOULD ATTEND:
Those who are involved with the design, development, analysis, validation, monitoring, transfer, and updating of biological assays will benefit from this course. This includes bench scientists, assay managers, those responsible for planning and analyzing bioassay validation experiments, statisticians who are new to bioassay, as well as managers who have responsibility for bioassay development and validation. The course focuses on key concepts, and properties of bioassays, with enough details to understand how medical needs drive product specifications, which drive the requirements for assay capabilities. We will not focus on formulae or calculations. We will discuss the strengths and weaknesses of various big-picture approaches to bioassay development and validation.