The aim of this Action was to improve the accuracy of predictions based on the scientific information gathered during the development of new drugs to ensure that they are both efficacious and safe and are also sustainable A position paper was published in the European Journal of Pharmaceutical Sciences about modelling in phase 1 studies and simulation in clinical drug development. This particularly underlined the interest of the topic within the pharmaceutical industry. An expert meeting on “In vitro Prediction of Gastrointestinal Absorption and Bioavailability” discussed the state of the art, problem areas and future directions in predicting the absorption of drugs and other chemicals following exposure via the oral route. Invited experts from industry demonstrated the importance of this topic in pharmaceutical R & D and the Action produced a consensus paper which has been published in the European Journal of Clinical Pharmacology. An expert meeting on “In silico Prediction of Pharmacokinetics” demonstrated, and evaluated six software packages used by various producers. This resulted in a position paper which has been published in European Journal of Pharmaceutical Sciences. A debate took place on “In vitro approaches to predict kinetics and dynamics in vivo with input Molecular Approaches to the Identification of Biomarkers of Exposure and Effect” extensively covered the use of the main ‘omics’ approaches to identification, selection, and validation of biomarkers. The Action also addressed the topic of “Validation of in Silico Approaches to the Prediction of Gastrointestinal Absorption and Drug Metabolism” and outlined potential and promising prerequisites and approaches to the validation of in silico methods from points of view of drug and chemical industry, regulatory agencies and academia. All participants, whether from academia, regulatory bodies or drug or chemical industry, were of the opinion that the meeting was timely and useful. A draft position paper was prepared. The final output of the Action B15 will be the publication of a special issue of the basic and clinical pharmacology and toxicology in 2005 in which the main results obtained by the network will be published.
