Price may vary based on selected course content, please email Narayan.Srivastav@usp.org for additional information.
This hands-on bioassay laboratory-based course focuses on USP General Chapters <1030>, <1032>, <1033> and <1034> along with laboratory execution of bioassay procedures. In this highly interactive course, participants will learn key concepts of in vitro bioassays, including use of relevant terminology, best practices, design, development, validation, post-validation, analysis, interpretation and reporting of results. It’s a great opportunity for those who wish to understand the best practices for analysis and consistent interpretation of data obtained from method development and validation. Scientists also gain hands-on laboratory experience and learn about the application of appropriate statistical tools for data analysis.
Upon completion of this course, you will be able to:
- Successfully execute the Bioassay procedure
- Select and apply appropriate statistical approaches to bioassay practices.
- Explain elements of data analysis.
- Implement best practices in laboratory execution of a bioassay procedure.
- Describe fundamental concepts of bioassay validation, including protocol design, strategies and parameters as they relate to the topics selected
- Select the number of determinants for reporting of results using 95 percent confidence limits for the mean measured potency and format variability post-validation. (when the full course is selected).
- Explain fundamental concepts of assay design and development (when the full course is selected).
Who Should Participate?:
Biopharmaceutical/pharmaceutical professionals who perform, supervise, manage and/or oversee R&D or QC activities, such as design, development, analysis and validation of cell-based and cell-free (ELISA) potency assays as per USP General Chapters <1032>, <1033> and <1034> for peptides, proteins, monoclonal antibodies, vaccines, blood factors and antibiotics.