ABSTRACT
This chapter deals with a brief overview of Quality Control (QC) because at the time of writing there is the potential for significant change in the bioanalytical world of Biomarker measurement in drug development. In order to understand the expectations for QC, it is necessary to first understand what is meant by the term “Quality Control” from the perspective of the analytical laboratory. QC challenges in multiplexed assays are often overcomplicated by the choice of the actual assays themselves. The ideal for QC samples is that they are fully representative of the samples to be measured. Endogenous QCs (EQC) are the ideal for all biomarker analytical work. Different levels of EQCs can be created by mixing low and high concentration samples at different ratios, but again this will only result in producing EQCs for those biomarkers that are present in significant concentrations after pooling.
