Abstract
Clinical study plan for DDS preparations is dependent on available clinical data and design of the original non-DDS drug, overseas data, standard therapy, patient population, and so on. Most important element to be considered is to demonstrate clinical benefit over the non-DDS preparation and/or standard therapy in time course of pharmacokinetics/pharmacodynamics, clinical efficacy, and safety. In this article, general guidelines, though they are not specific to DDS preparations, to be considered for clinical developments of DDS preparations and examples of clinical Droaram on several DDS preoarations are summarized.
