ABSTRACT
Efficacy and safety of a new medicinal product are established in phase III trials conducted in a selected group of patients. In fact, with the aim to reduce the variability, there have been an increasing number of inclusion and exclusion criteria imposed in the phase III studies submitted to the Medical Products Agency in Sweden over the last 10 years. However, when approved, the product is often used in a wider group of patients. To compensate for this discrepancy the pharmaceutical industry and regulators use pharmacokinetic data, together with studies in animals, to identify subgroups of patients where the exposure is changed to an extent that they should not be treated with the medicinal product, or the dose needs to be adjusted. The aim of this chapter is to discuss disease states that may influence the pharmacokinetics of a medicinal product. References are made to a number of regulatory guidelines. It is, however, important that these are considered to be guidelines and nothing more than guidelines. Each new drug has its own characteristics and should be developed according to current scientific standards.
