The main objective of the COST Action B25 is to improve the utility and interpretation of
scientific information obtained either during product development or, subsequently, through
observations in humans, to predict the safe and effective use of drugs and other chemicals.
Exposure to drugs and other chemicals is expressed in terms of the mass of compound.
However, it is the concentration of the compound that determines the magnitude of interaction
with the molecular targets responsible for the desirable and for the undesirable effects of these
chemicals. Physiologically based approaches provide a mechanistically-based means of
relating external exposure to internal, or active site, concentration and effect, permitting
extrapolation throughout a wide range of circumstances, whilst providing insight into the
fundamental processes involved.
Physiologically based approaches are potentially very powerful, and can assist in product
development, by improving compound selection, in the design and interpretation of premarketing
studies, in dose selection in different patient groups, in assessing the extent and
causes of interindividual variation in response and in the risk assessment of drugs and other
chemicals, including quantitative extrapolation from experimental animals to man. Such
approaches also provide unparalleled opportunities for the application of in vitro and
computer-based techniques, to acquire the appropriate parameters, and thereby reduce or
replace animal experimentation.
Hence, the COST Action B25 will provide a highly effective means of improving interaction
between scientists from Academia, Industry and Governmental sectors.
The working framework of the Action is based on the experience gained during previous
Actions, COST B1 and COST B15. Both COST Actions were very effective in facilitating the
exchange of information between the various interested parties in the fields of drug
development and drug and chemical safety. This ranged from in vitro studies of kinetic and
dynamic processes, biomarkers of clinical effect, to models of disease progression and the
simulation of clinical trials. Both COST Actions were also effective in stimulating European
research in the respective areas. Whilst COST Action B15 was concerned with modelling,
physiologically based approaches were not addressed. Nevertheless, during the COST Action
B15 it became apparent that such approaches have considerable potential and that they would
benefit considerably from a dedicated COST Action. Hence, the COST Action B25 is built
upon, but distinct from, these previous COST Actions.
