ABSTRACT

I will commence this section with a brief overview of Quality Control (QC) because at the time of writing there is the potential (and need) for significant change in the bioanalytical world of Biomarker measurement in drug development. Therefore, for those Bioanalytical scientists who have only thus far focused on Pharmacokinetic (PK) assays and applied standard PK acceptance rules, this will be a major change from the current criteria applied for those assays and recommended in regulatory guidance documents.