生物类似药科学——更新可互换性 - Suppr

The Science of Biosimilars-Updating Interchangeability.

作者信息

Cavazzoni Patrizia, Yim Sarah

机构信息

Center for Drug Evaluation, US Food and Drug Administration, Silver Spring, Maryland.

Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, US Food and Drug Administration, Silver Spring, Maryland.

出版信息

JAMA. 2024 Oct 15;332(15):1235-1236. doi: 10.1001/jama.2024.15225.

DOI:10.1001/jama.2024.15225

PMID:39292484

Abstract

摘要

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The Science of Biosimilars-Updating Interchangeability.

JAMA. 2024 Oct 15;332(15):1235-1236. doi: 10.1001/jama.2024.15225.

Interchangeability Of Biological Drug Products-FDA Draft Guidance.

J Biopharm Stat. 2019;29(6):1003-1010. doi: 10.1080/10543406.2019.1607369. Epub 2019 Apr 25.

Some thoughts on drug interchangeability.

J Biopharm Stat. 2016;26(1):178-86. doi: 10.1080/10543406.2015.1092027.

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PLoS One. 2022 Jan 11;17(1):e0262537. doi: 10.1371/journal.pone.0262537. eCollection 2022.

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Curr Med Res Opin. 2019 Apr;35(4):619-621. doi: 10.1080/03007995.2018.1560223. Epub 2019 Jan 17.

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Future Oncol. 2019 Mar;15(7):777-790. doi: 10.2217/fon-2018-0680. Epub 2018 Nov 30.

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Curr Rheumatol Rep. 2016 Mar;18(3):16. doi: 10.1007/s11926-016-0564-1.

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引用本文的文献

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Incorrect Wording.

JAMA. 2024 Nov 26;332(20):1761. doi: 10.1001/jama.2024.23634.

The Science of Biosimilars-Updating Interchangeability.

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The Science of Biosimilars-Updating Interchangeability.

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