Considerations for the design and conduct of externally controlled trials for drug and biological products
This guidance provides recommendations to sponsors and investigators considering the use of externally controlled clinical trials to provide evidence of the safety and effectiveness of a drug product. In an externally controlled trial, outcomes in participants receiving the test treatment according...
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| Main Authors: | , |
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| Format: | Article |
| Language: | Russian |
| Published: |
Publishing House OKI
2023-12-01
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| Series: | Реальная клиническая практика: данные и доказательства |
| Subjects: | |
| Online Access: | https://www.myrwd.ru/jour/article/view/51 |
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