纳米药物与纳米类似物——为何强大的集中监管框架对提高患者安全性至关重要。 - Suppr

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超能文献

Nanomedicines and Nanosimilars-Why a Robust Centralised Regulatory Framework Is Essential to Enhance Patient Safety.

作者信息

Isles Michael P

机构信息

European Alliance for Access to Safe Medicines, Dublin, Ireland.

出版信息

Front Pharmacol. 2022 Feb 24;12:787239. doi: 10.3389/fphar.2021.787239. eCollection 2021.

DOI:10.3389/fphar.2021.787239

PMID:35280250

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8907565/

Abstract

摘要

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0a1/8907565/cfa3ad9daf61/fphar-12-787239-g001.jpg

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本文引用的文献

The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations.欧盟非生物复杂药物（NBCD）仿制药监管格局：观察与建议。

Eur J Pharm Sci. 2019 May 15;133:228-235. doi: 10.1016/j.ejps.2019.03.029. Epub 2019 Apr 3.

Reflections on FDA Draft Guidance for Products Containing Nanomaterials: Is the Abbreviated New Drug Application (ANDA) a Suitable Pathway for Nanomedicines?对 FDA 含纳米材料产品指南草案的思考：简化新药申请 (ANDA) 是否适合纳米药物？

AAPS J. 2018 Aug 20;20(5):92. doi: 10.1208/s12248-018-0255-0.

Markers of oxidative/nitrosative stress and inflammation in lung tissue of rats exposed to different intravenous iron compounds.暴露于不同静脉注射铁化合物的大鼠肺组织中氧化/亚硝化应激和炎症的标志物。

Drug Des Devel Ther. 2017 Aug 1;11:2251-2263. doi: 10.2147/DDDT.S132612. eCollection 2017.

Efficiency of Original versus Generic Intravenous Iron Formulations in Patients on Haemodialysis.血液透析患者中原始静脉铁制剂与通用静脉铁制剂的疗效比较。

PLoS One. 2015 Aug 31;10(8):e0135967. doi: 10.1371/journal.pone.0135967. eCollection 2015.

Nitrosative stress and apoptosis in non-anemic healthy rats induced by intravenous iron sucrose similars versus iron sucrose originator.静脉注射蔗糖铁类似物与蔗糖铁原研药对非贫血健康大鼠的亚硝化应激和细胞凋亡的影响

Biometals. 2015 Apr;28(2):279-92. doi: 10.1007/s10534-015-9822-3. Epub 2015 Jan 22.

The pharmacokinetics and pharmacodynamics of iron preparations.铁制剂的药代动力学和药效学。

Pharmaceutics. 2011 Jan 4;3(1):12-33. doi: 10.3390/pharmaceutics3010012.

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