Bioanalytical methods validation: A critique of the proposed FDA guidance

The criteria generally applied to the validation of bioanalytical methods are largely based on the Consensus meeting held in Washington in 1990 in a number of Journals. In December 1998, the FDA published Draft Guidelines for Human Bioanalytical studies, based on the 1990 Consensus report. Subsequently a meeting Bioval 99 was held in June 1999 in London and a workshop jointly organised by the FDA and AAPS was held in Crystal City. Points emerging from the latter meeting appear in an Addendum (p. S-67). The present article was written in advance of it las was Muirhead's art, p. S-72-Ed.].