TOPICS TO BE COVERED INCLUDE:

• USP <1033> - What Does It Mean for a Bioassay to be “Suitable for Intended Use”?
• The Role of Statistics in the Development of Biologics and Lot Release Specifications
• Assays, Measurements, Averaging, and the Meaning of Uncertainty        
• Accuracy vs Precision
• Populations vs Samples
• Parameters vs Statistics
• The Normal Distribution
• Inferential Statistics and Sampling Error
• Standard Error of the Mean 
• t values and p values
• Confidence Intervals
• Difference vs Equivalence Testing
• Type I and Type II Errors and Statistical Power
• Dose-Response Curve Models
• Log Transformation of Bioassay Readouts and Relative Potency Values
• Selecting Software for Bioassay Analysis
• Interpreting ICH Assay Validation Guidance
• Critical Fold Difference as a Metric for Evaluating Bioassay Precision to Support Early Phase Trials
  
  

The commitment to participants:  Each participant is likely to arrive at the course with the expectation of examples or explanations to address issues that are specific to them or their organization. To ensure that participants are satisfied, the instructor is open to receiving non-confidential questions in advance for consideration in customizing the course material. The instructor will assess each question to ensure it matches the scope of the workshop.

WHO SHOULD ATTEND

• Laboratory scientists, technicians and others with limited statistical knowledge who are involved in generating and reporting data
• Managers in QA, QC and Regulatory functions who review data and statistical analyses
• Non-statisticians who engage with statisticians in the design and interpretation of studies
• Technicians involved in design, execution or review of assay qualification protocols
• Anyone interested in increasing their understanding of basic statistical concepts and improving their comprehension of conference presentations that include statistical analyses