Regulatory benefit–risk assessment of oncology drugs: A systematic review of FDA and EMA approvals

Author:

Pinto Cathy Anne,Balantac Zaneta,Mt-Isa Shahrul,Liu Xinyue,Bracco Oswaldo L,Clarke Harrison,Tervonen Tommi

Funder

Merck Sharp and Dohme

Publisher

Elsevier BV

Subject

Drug Discovery,Pharmacology

Reference44 articles.

1. European Medicines Agency. Benefit-risk methodology. Research projects. Accessed July 16, 2020. https://www.ema.europa.eu/en/about-us/support-research/benefit-risk-methodology.

2. IMI-PROTECT. What is benefit-risk assessment? Accessed July 16, 2020. http://protectbenefitrisk.eu/PPI2.html.

3. Structured benefit-risk assessment across the product lifecycle: practical considerations;Smith;Ther Innov Regul Sci,2017

4. Can standardisation of the public assessment report improve benefit-risk communication?;Keyter;Front Pharmacol,2020

5. Structured frameworks to increase the transparency of the assessment of benefits and risks of medicines: current status and possible future directions;Pignatti;Clin Pharmacol Ther,2015

Cited by 1 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. Medical Statistics in Drug Development and Regulatory Approval;Advances in Bioinformatics and Biomedical Engineering;2024-07-18

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