This group focuses on technologies and issues pertaining to the bioanalysis of analytes by nonchromatographic assays, including binding assays, immunoassays, and activity- and cell-based assays. Some specific goals are to:
- discuss issues that impact the validation and application of nonchromatographic assays;
- seek an industry consensus for prestudy and instudy validation of nonchromatographic assays;
- discuss the role of statistical design and analysis as a means for enhancing the reliability of nonchromatographic assays;
- serve as a forum to discuss emerging nonchromatographic technologies and automation used in the bioanalysis of small molecules and biotechnology products; and
- discuss issues concerning the validation and application of in vitro assays for the quantification of biomarkers.
The group's mission is to provide a forum to address issues and promote education for the bioanalysis of small molecules, biotechnology products, and pharmacodynamic biomarkers by ligand binding assays and related analytical methodologies that are based on macromolecular interactions. Some specific examples of ligand binding assays include immunoassays, activity- and cell-based assays, and assays employing oligos (primers) of DNA/RNA.
Section affiliations: APQ | BIOTEC