Bioassay development and validation is very critical in pre-clinical drug discovery, clinical biomarker and translational research, diagnostic product (including companion diagnostic) development. In this presentation, overview if given for the terminologies, the scientific principles, and the regulatory guidelines that are related to assay validation.
Then each of the assay performance characteristics (specificity, sensitivity, accuracy, precision, linearity, stability, reportable range, reference range) will be explained in terms of experimental design and statistical analysis.
Most assay validations are a compromise between scientific principles, regulatory requirements, and limited resources in reality. The webinar will use real life examples to demonstrate how to overcome some of the practical challenges when guidelines can not be exactly followed
Why should you Attend: Though the CLSI guidelines provide much more actionable details than other guidelines (e.g. by FDA, USP), the understanding and adoption of the guidelines remains a challenge for the broad users. Plus, due to reality restraints, oftentimes the study design and/or the statistical analysis suggested by the guideline cannot be exactly followed.
In this webinar, major CLSI EP guidelines will be introduced. The focuses are (1) interpreting the procedure for each guideline, (2) intuitive explanation of the statistical methodologies, (3) using real-life examples to illustrate the use of the guidelines, and (4) discussing some solutions when facing challenges in implementing the guidelines.
Areas Covered in the Session:
Overview of Biomarker Development
CLSI Assay Validation Guidelines
Matrix effect (EP14)
Statistical Process Control (SPC)
- Preclinical R&D Scientists
- Clinical Labs
- Translational Research
- Diagnostic Labs
- Lab CRO
- Quality Control
• Preclinical R&D Scientists
• Clinical Labs
• Translational Research
• Diagnostic Labs
• Lab CRO
• Quality Control