Risk management for quality assurance of preclinical research

Risk management for quality assurance of preclinical research

The article discusses various aspects of risk management for quality assurance (QA) of preclinical studies of drugs. The authors analysed risk management methods and approaches, and defined relevant risk management methods to be used in preclinical studies performed according to ISO 9001 and the Goo...

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Bibliographic Details
Main Authors: E. D. Burova, S. V. Khodko, S. V. Gushchina, M. N. Makarova, V. G. Makarov
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2018-02-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
управление рисками
доклинические исследования
система управления рисками
методы оценки рисков
обеспечение качества
risk management
preclinical research
risk management system
methods of risk assessment
quality assurance
Online Access:https://www.vedomostincesmp.ru/jour/article/view/114

Internet

https://www.vedomostincesmp.ru/jour/article/view/114

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