Jan 31, 2022 10:34
2 yrs ago
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English term

Guideline on the Evaluation of Anticancer Medicinal Products in Man

English to Russian Medical Medical: Pharmaceuticals
The randomized trial design and the selection of PFS as the primary endpoint are based on considerations outlined in the FDA Guidance for Industry “Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics” and the European Medicines Agency (EMA; “Guideline on the Evaluation of Anticancer Medicinal Products in Man”, EMA/CPMP/205/95 Rev.5) for approval of anticancer drugs.

Proposed translations

+1
5 mins
Selected

«Руководство по оценке противоопухолевых лекарственных средств для применения у человека

руководство является дополнением к таковому по оценке противоопухолевых лекарственных средств для применения у человека https://gxpnews.net/2016/04/ema-vypustilo-rekomendacii-o-pro...

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Note added at 5 days (2022-02-05 15:06:44 GMT) Post-grading
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Cпасибо, Анастасия!
Peer comment(s):

agree Natalia Novichenko
3 mins
Thank you very much, Natalia!
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