RQAP re-registration units: 1 non-GCP, non-GLP
*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.
DescriptionProvide an overview of the science behind Ligand Binding Assays used in regulated bioanalysis. The course will cover both PK and ADA assays, and describe some of the areas where auditors should focus their review.
ObjectivesAt the end of the course, the participants shall be able to:
- Overview of the science of ligand binding assays (LBAs)
- PK LBAs
- ADA LBAs
- Bioequivalence vs. Biosimilars
- Biomarkers
Target AudienceAuditors new to bioanalysis and new to auditing large molecules.
Agenda- Overview of the science of ligand binding assays (LBAs)
- PK LBAs
- ADA LBAs
- Bioequivalence vs. Biosimilars
- Biomarkers