[Drug registration file prerequisites for European procedures]

The pharmacokinetic content of the drug registration file is now well standardized. The objectives of the pharmacokinetic documentation is to provide evidence supporting the dosing regimen in patients, to take into account the pathophysiological states of the populations at risk and to anticipate drug-drug interactions. Recommendations on study design and evaluation of parameters of interest are listed in various documents Issued by the Committee for Proprietary Medicinal Products and the International conferences on Harmonization, i.e. the Concept Papers, the Points to Consider and Notes for Guidance. The pharmacokinetic data of the registration file are used to document many sections of the Summary of the Product Characteristics.