2019 PharmSci 360
Making the right interpretation of biomarker data relies on the expertise of the scientist and the quality of the measurement methods. Well established reagents are key to achieving an assay that is robust, specific and sensitive. The quality assurance of critical reagents is a topic discussed by the bioanalytical community, both by regulatory and sponsor perspectives.
Through the use of case studies, this talk will convey an understanding of how critical reagents are defined, characterized and controlled. Case studies also guide us on the management of critical reagents when problems arise and how corrective actions can be applied.