Journal of Bioequivalence & Bioavailability

Harmonizing best practices in bioanalytical methods

3^rd World Congress Bioavailability & Bioequivalence

March 26-28, 2012 Marriott Hotel & Convention Centre, Hyderabad, India

Maha Tutunji

Scientific Tracks Abstracts: J Bioequiv Availab

Abstract:

A pplication of chromatographic methods to quantitatively determine active drug constituents in biological matrices continues to be the subject of much debate. The definitions of validation parameters required in support of bioavailability, bioequivalence and pharmacokinetic studies have been suggested by scientists and regulators from the US Food and Drug Administration (FDA), the European Medicines Agency (EMEA), the UK Medicines Control Agency, the International Conference on Harmonization (ICH) and similar bodies from Canada, Japan and other countries. At the interface between the bioanalyst and the regulator, problems still occur due to the following reasons: (1) the problem-solving role of chemical analysis is not emphasized as a process or a chain of operations, as a consequence, bioanalysts are consigned to pigeonholes where they function as sample drop-off points, rather than active participants in solving analytical problems, (2) many of the technical terms used for evaluating analytical methods in different sectors of analytical measurements vary in terms of their definition and method of determination, (3) little emphasis was given to method development procedures and its merits of performance, which has also been confused with method validation processes, (4) the application of statistical methods to method development and validation data was relegated to a subordinate role in validation literature. Consequently, acceptance criteria was generalized while quantifying uncertainty was casually mentioned, (5) fitness for purpose bioanalytical methods were not emphasized nor practiced, and (6) both the analytical and pharmaceutical sciences are dynamic disciplines in which today?s regulations do not fit tomorrow?s problems. The above contributed to the misinterpretation of guidances among non-research based bioanalytical laboratories and regulators in different parts of the world. Examples will be presented based on experience with 400 bioequivalence studies.