REGULATORY STRATEGY OF CLINICAL DEVELOPMENT FOR FIXED COMBINATION MEDICINAL PRODUCTS

This article is intended for specialists on drug registration and specialists in clinical trials. There are analyzed the main projects of foreign documents regulating the amount of the registration program and the program of clinical trials required to bring to market the combined drugs. Article cla...

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Bibliographic Details
Main Authors: K. A. Yatsenko, V. S. Berezina
Format: Article
Language:Russian
Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2019-01-01
Series:Разработка и регистрация лекарственных средств
Subjects:
Online Access:https://www.pharmjournal.ru/jour/article/view/179