Differences in product information of biopharmaceuticals in the EU and the USA: implications for product development
Author:
Publisher
Elsevier BV
Subject
Pharmaceutical Science,General Medicine,Biotechnology
Cited by 19 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. Inconsistencies of absolute drug–drug contraindication reports: Analysis of Summaries of Product Characteristics of commonly prescribed drugs;British Journal of Clinical Pharmacology;2023-04-17
2. Inconsistencies and Ambiguities in Liver-Disease-Related Contraindications—A Systematic Analysis of SmPCs/PI of Major Drug Markets;Journal of Clinical Medicine;2022-03-30
3. A systematic comparison of hepatobiliary adverse drug reactions in FDA and EMA drug labeling reveals discrepancies;Drug Discovery Today;2022-01
4. Discrepancies Between the Labels of Originator and Generic Pharmaceutical Products: Implications for Patient Safety;Drugs - Real World Outcomes;2020-04-22
5. A Qualitative Study on the Differences Between Trial Populations and the Approved Therapeutic Indications of Antineoplastic Agents by 3 Regulatory Agencies From 2010 to 2018;Clinical Therapeutics;2020-02
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