ABSTRACT
Pharmacology studies will have been carried out during the drug design process, but further studies may need to be carried out in order to define the activity of the drug and to provide a better insight into its mechanism of action. In vivo and in vitro studies are also carried out to see whether the drug has any other pharmacological activity apart from the one of interest. Formulation studies start in advance of clinical trials, but are unlikely to be complete until after clinical trials have started. Preformulation involves the characterization of a drug’s physical, chemical and mechanical properties in order to choose what other ingredients should be used in the preparation. By the time phase III clinical trials are reached, formulation of the drug should have been developed to be close to the preparation that will ultimately be used in the market. The drug preparation is tested for stability when stored at room temperature and at various other temperatures.
