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PART III DEVELOPING CLINICAL RESEARCH TRIALS

INTRODUCTION The clinical development of pharmaceutical products is the most important part of the new drug approval process. It is the part of an NDA/CTD submission that determines whether or not regulatory agencies, throughout the world, will approve the product to be marketed to the public. Clinical research is often the most expensive and time-consuming step in product development. Accomplishing this task requires careful scientific and strategic planning in order to meet the research objective of proving the product is not only safe for human use but also effective.