CLINICAL DEVELOPMENT STRATEGY FOR COPIES OF PREVIOUSLY REGISTERED DRUGS. PART 3. PROTOCOL OF CLINICAL TRIAL OF BIOEQUIVALENCE

Recommendations presented in the article are based on current regulations and guidelines of regulatory authorities on clinical trials of bioequivalence and professional experience of authors and will be useful for medical writers to plan clinical trial lege artis. Article gives information about cho...

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Bibliographic Details
Main Authors: K. A. Yatsenko, E. A. Kuznetsov, A. V. Arkadjeva, 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/97