Clinical trials of a medicinal product
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Главная Documents Vocabulary Clinical trials of a medicinal product
Clinical trials of a medicinal product

Clinical trials of a medicinal product are studies of diagnostic, therapeutic, prophylactic and pharmacological properties of a medicinal product in the process of use thereof by a human being or an animal, including, but not limited to the processes of absorption, allocation, modification and excretion, by means of scientific methods of assessment for the purpose of obtaining evidence of safety, proper quality and efficacy of the medicinal product, data on adverse reactions of the use of the medicinal product by a human being or an animal, and the effect of interaction thereof with other medicinal products and (or) food substances, or animal food substances

Source: Russian Federation Law №61-FZ March 24, 2010 "On Circulation of Medicines"

 
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