Are we approaching the post-blockbuster era? Pharmacodiagnostics and rational drug development.

In the future, it may be a pharmacodiagnostic test that decides which drug to choose for the individual patient and, to a much lesser extent, the average results from large randomized clinical trials or the marketing efforts of the pharmaceutical companies. Personalized medicine or stratified medicine should be regarded as the 21st Century's answer to the rational use of drugs--the right drug for the right patient at the right time. The new molecular diagnostic methods will provide the pharmaceutical companies with a powerful tool that will enable them to make a more objective decision with respect to their drug development. Furthermore, introducing pharmacodiagnostic testing in a drug development program could lead to a considerable reduction in both development costs and time. The change from blockbuster medicine to stratified and personalized medicine must be regarded as a major challenge for pharmaceutical companies, but also a challenge that could lead to a much more rational drug development process.