ANALYSIS OF INTERNATIONAL REQUIREMENTS FOR DESIGNING OF CLINICAL TRIALS

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ANALYSIS OF INTERNATIONAL REQUIREMENTS FOR DESIGNING OF CLINICAL TRIALS

During the analysis of international requirements for designing of clinical trials we found that principal documents are provided by ICH. The main standard in Russian Federation is the National State Standard “Good Clinical Practice”, that is similar to ICH GCP. Thorough industrial standards are iss...

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Bibliographic Details
Main Authors:	O. S. Kobyakova, E. S. Kulikov, I. A. Deev, A. A. Dmitriev, N. A. Tabakaev, I. D. Pimenov, D. S. Tyufilin
Format:	Article
Language:	Russian
Published:	LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2019-01-01
Series:	Разработка и регистрация лекарственных средств
Subjects:	clinical trials design harmonization regulator y requirements ich fda ema
Online Access:	https://www.pharmjournal.ru/jour/article/view/99
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