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...

Descrizione completa

Salvato in:
Dettagli Bibliografici
Autori principali: O. S. Kobyakova, E. S. Kulikov, I. A. Deev, A. A. Dmitriev, N. A. Tabakaev, I. D. Pimenov, D. S. Tyufilin
Natura: Artigo
Lingua:Russo
Pubblicazione: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2019-01-01
Serie:Разработка и регистрация лекарственных средств
Soggetti:
clinical trials design
harmonization
regulator y requirements
ich
fda
ema
Accesso online:https://www.pharmjournal.ru/jour/article/view/99
Tags: Aggiungi Tag
Nessun Tag, puoi essere il primo ad aggiungerne! !

Documenti analoghi