Current approaches to global drug development from a European perspective
In view of the current costs of new drug development, for a company to be successful it must have a strategic plan for the global development of its new chemical entities.
Global development can be defined as an attempt to reach all major markets as rapidly as possible in a cost effective and efficient manner. For some companies this will include the United States, Japan, Germany, France, Italy, UK and Canada which represents approximately 85% of the developed pharmaceuticals world.
Successful global drug development should result in a single data sheet/package insert with one set of utility statements for the product. Unfortunately, differences in medical practice including differences in diagnosis, treatment and clinical research methodology in various countries can swamp all the attempts to achieve a global programme. Ultimately, meaningful clinical harmonisation between Japan and the Western World, although seemingly remote at the present time, would have a significant impact on the global development of new medicines.
KeywordsBrief Psychiatric Rate Scale Global Development Utility Statement European Perspective Trial Programme
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