The decision about reporting a specific analyte on the CoA is typically linked to
specifications. After the decision about integration has been made for all analytes resolved
(defined) by the method, the results are recorded in the database (e.g. LIMS). When all
analytical tests are completed, the manufacturer creates the CoA by extracting the relevant
information from the database. Only a subset of the results, which are defined by
specifications, will be listed on the CoA. The specifications will depend on the extent of peak
characterization and the clinical significance of the various peaks (Apostol, Schofield et al.
2008). Therefore, the list will change (evolve) with the stage of drug development. In such a
context, LOQ should be considered as the analyte specific value expressed in units of
protein concentration, a calculation for which instrument sensitivity cannot be disregarded
(in contrast to LOD estimation). This indicates that a potential exists for diverse approaches
to the practice of determining the LOD and LOQ.