Bioanalytical methods validation: A critique of the proposed FDA guidance

The criteria generally applied to the validation of bioanalytical methods a re largely based on the Consensus meeting held in Washington in 1990 in a n umber of Journals. In December 1998, the FDA published Draft Guidelines for Human Bioanalytical Studies, based on the 1990 Consensus report. Subsequen tly a meeting Bioval99 was held in June 1999 in London and a workshop joint ly 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 articl e was written in advance of it [as was Muirhead's art., p. S-72 - Ed.]. Bioanalysis, in this context, is a term that has been applied for over 30 y ears to the quantitation of drugs (therapeutic agents) in biological matric es, usually plasma, serum or blood for the purposes of defining their pharm acokinetics. More recently with the ascendancy of biotechnology, this term has been adopted by protein chemists to define the analytical methods used for characterising proteins. This article amplifies a previous article in t his series [1]1) following the publication of the recent FDA guidance and i ncorporates recent thought as discussed in Bioval 99. Recently the FDA published "Guidance for industry; Bioanalytical Methods Va lidation for Human Studies", in January 1999, with a requirement for commen ts to be provided within sixty days. These guidelines were based on the con sensus meeting held in December 1990, ai Crystal City Arlington, Washington DC (organised by AAPS, FIPS, HPB, AOAC and the FDA). These Crystal City Gu idelines, or Shah (the senior author) guidelines as they have become variou sly known, were published in a variety of journals in 1992 [2], and since t hat time have gained universal acceptance throughout the pharmaceutical ind ustry The AAPS and FDA have organised a further meeting, Crystal City (revi sited) 2000 to be held in Crystal City in January 2000. As such the propose d FDA Guidance for industry are in abeyance until a further consensus is re ached. As part of this consensus process the RSC and RPS (GB) in the form of JPAG and the PSG, together with EUFEPS organised a European based meeting in Jun e last year in London (Bioval 99) in order to provide a European perspectiv e.