Bioassay Development, Validation and Control

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.

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 2: Bioassay Development ANCOVA PLA Linear

Dose Response and Masking
Curve Weighting
Outlier Analysis
Parallelism Assessment
Selecting Validity Criteria and Systems Suitability

Section 3: 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 4: 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