Changing paradigms in bioequivalence trials submitted to the EMA for evaluation - A clinical and regulatory perspective.

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作者： Nathaniel,Refalo ^[1] ; Daniel,Chetcuti ^[1] ; Amy,Tanti ^[1] ; Anthony,Serracino-Inglott ^[2] ; John Joseph,Borg ^[3]

作者单位： Medicines Authority, Sir Temi Żammit Buildings, Malta Life Sciences Park, San Ġwann, Malta. ^[1] Medicines Authority, Sir Temi Żammit Buildings, Malta Life Sciences Park, San Ġwann, Malta; Department of Pharmacy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta. ^[2] Medicines Authority, Sir Temi Żammit Buildings, Malta Life Sciences Park, San Ġwann, Malta; Department of Biology, School of Pharmacy, University of Tor Vergata, Rome, Italy. ^[3]

关键词 API, active pharmaceutical ingredient BCS, Biopharmaceutics Classification System (BCS)BE, bioequivalence BSA, body surface area Bioequivalence CHMP, Committee for Medicinal Products for Human Use EMA, European Medicines Agency EPAR, European Public Assessment Report EU, European Union Generic medicinal products MA, marketing authorisation Marketing authorisation NHS, National Health System

DOI 10.1016/j.jsps.2016.07.005

PMID 28344480

发布时间 2020-10-01

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Saudi pharmaceutical journal

2017年25卷2期

280-289页

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Changing paradigms in bioequivalence trials submitted to the EMA for evaluation - A clinical and regulatory perspective.

Saudi pharmaceutical journal

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Saudi pharmaceutical journal

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Changing paradigms in bioequivalence trials submitted to the EMA for evaluation - A clinical and regulatory perspective.

Saudi pharmaceutical journal

相似文献

Saudi pharmaceutical journal

相关期刊

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