Phase II Clinical Development

Authored by: Naitee Ting , Guojun Yuan

Encyclopedia of Biopharmaceutical Statistics

Print publication date:  August  2018
Online publication date:  August  2018

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:


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Most of the drugs available in pharmacy started out as a chemical or biological compound discovered in laboratories. A chemical compound is relatively a smaller molecule synthesized in a laboratory, whereas a biological compound tends to be a large molecule extracted from living bodies, such as plant or animal tissues. When first discovered, this new compound is denoted as a product candidate. Medicinal product development is a process that begins when the product candidate is first discovered and continues until it is available to be prescribed by physicians to treat patients. It is usually a new chemical or biological entity synthesized by scientists from pharmaceutical companies, universities, or other research institutes. This new compound will have to undergo the product development process and obtain regulatory approval before it can be used by the general patient population.

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