Abstract
Worldwide politico-socioeconomic factors greatly influence the regulations and legislation that govern the clinical study of investigational new drugs. The increase in worldwide potential for pharmaceutical products, along with the escalating research and development expenditures, place an increased responsibility on R&D to produce new and improved products with worldwide clinical utility. Worldwide regulatory agencies play a significant role in the design and study of new drugs and in the transport of clinical drug supplies. The extent and influence of worldwide regulations on the clinical development of drugs for worldwide markets and on the transport of clinical drug supplies both now and in the future are presented.
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