Bioassay Development, Validation and Control
Course Description
This course is specifically designed to meet the analytical needs of those individuals working within FDA regulated industries. Areas of focus are in-vivo and in-vitro bioassays using nonlinear and linear regression and ANCOVA. This course requires 16 hours of instruction.
Attendees
This course is required for those individuals that directly work on bioassay development, method validation and control.
Prerequisites
Statistical Methods and Data Analysis is recommended prior to this course but not required. SAS/JMP version 11,12 or 13.
Detailed Course Outline
Section I: Bioassay Development, Nonlinear
- USP and EU guidance
- Dose Response
- Log and Antilog of Log and Log10
- Curve Weighting
- Outlier Analysis
- Parallelism Assessment
- Selecting Validity Criteria and Systems Suitability
Section II: Bioassay Development ANCOVA PLA Linear
- Dose Response and Masking
- Curve Weighting
- Outlier Analysis
- Parallelism Assessment
- Selecting Validity Criteria and Systems Suitability
Section III: Bioassay Validation and Acceptance Criteria
- Robustness
- Dilutional Linearity
- Accuracy
- Repeatability and Intermediate Precision using REML
- Assay Range
- Capability assessment, ATP profiler and design space
Section IV: Bioassay Control
- Tracking and trending
- EC50 Reference stability and CF
- Qualification of new reference lots and influence on relative potency and CF
- Sample size selection
