SC13: Bioassay Quality by Design
THURSDAY, APRIL 11, DINNER 5:45 - 8:15 PM (Federal Complex)
ABOUT THIS COURSE:
The course will present and discuss the critical elements of designing a bioassay. The course will include the following. The course is essential for those individuals designing or validating a bioassay.
TOPICS TO BE COVERED INCLUDE:
- Range Finder Study Design for Dose Selection
- Number of Doses in the dose response
- Number of Plates
- Plate Layout
- PLA versus 4PL fitting methods
- Outlier ID and Removal
- Dose Masking for PLA
- Robust Design and Optimization for a Bioassay
- Standard Selection and Qualification
- Validity and Systems Suitability criteria selection
- Validity and Systems Suitability setting limits
INSTRUCTOR BIOGRAPHY
Thomas Little, PhD, President and CEO, Bioassay Sciences, Thomas A. Little Consulting
Dr. Little is President of BioAssay Sciences (BAS) a globally recognized bioassay consulting company for biologicals and vaccines. BAS specializes in the design, calculation and control of potency and relative potency for bioassays. BAS specializes in In-Vivo and In-Vitro bioassays.
BAS works with international companies and health authorities globally to achieve product development goals aligned to ICH and USP guidance. BAS is a strategic partner of SAS/JMP and a division of Thomas A. Little Consulting.
Dr. Little has developed specific content courses in statistical methods and data analysis, Bioassay Design and Validation, Quality Risk Management, design of experiments, Robust Optimization, Design Space and Tolerance Design, Assay Development and Method Validation, statistical process control, mixture design of experiments, Stability Analysis and Nonlinear Modeling. These courses are used by a variety of fortune 100+ companies to train their chemists, engineers and scientists.