Bioanalytical method development: considering information from a suite of complementary methods

“Successful method development will discover data contradictions, deal with dilemmas, resolve or report difficulties and issues, incorporate additional changes, respond to new requirements, and address incoherent expectations.” Bioanalytical method development can be viewed as a science, an art, a fundamental part of the high-stakes game of pharmaceutical development or an admixture of the above. Specifications can change during development; the latter stages of method development may inconveniently unearth new interferences; clinical samples may show unexpected variation; there may be conflicts with other timelines.  Corporate stakes can be high, stratospheric even, before method development efforts have even begun. The completion of...