Controlling bioanalytical variability: a perennial quest

“It is possible to control or minimize bioanalytical variations, yet hard to eliminate, but at the same time conscious evasion can lead to erroneous conclusions.” Bioanalysis is an integral part of various drug-development processes, whether it is a new chemical entity for investigational new drug application or a generic version of an existing drug approved for abbreviated new drug application. The importance of HPLC/UPLC–MS/MS method can be envisaged from its role in PK and metabolism studies at various drug-development stages since its introduction to the pharmaceutical industry. Bioanalytical science has progressed significantly in the past two decades and the advancement...