CLINICAL STUDY REPORT: AN OVERVIEW OF REGULATORY DOCUMENTS AND THE ORGANIZATIONAL AND PRACTICAL ASPECTS OF DEVELOPMENT

Clinical study report is one of the main documents during the drug development. The preparation of the clinical study report requires knowledge of Russian and foreign legislation, awareness of guidelines and recommendatioins issued by the professional associations as well as the effective process ma...

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Bibliographic Details
Main Authors: E. A. Radkova, I. N. Petrova, K. A. Leus, I. A. Dobromyslov
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/526