Suppr超能文献

Current product equivalency issues.

作者信息

Gerrard T L

机构信息

Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, USA.

出版信息

Food Drug Law J. 1995;50(3):451-3.

Abstract
摘要

相似文献

1
Current product equivalency issues.
Food Drug Law J. 1995;50(3):451-3.
2
How good are our drugs?
Am J Hosp Pharm. 1970 May;27(5):367-74.
3
Lawsuits anticipated on generic biologicals front.
Nat Biotechnol. 2003 Jul;21(7):721-2. doi: 10.1038/nbt0703-721.
4
Polymorphism in generic drug product development.
Adv Drug Deliv Rev. 2004 Feb 23;56(3):391-5. doi: 10.1016/j.addr.2003.10.010.
5
Pre-approval inspections/investigations. Food and Drug Administration.
J Parenter Sci Technol. 1991 Jan-Feb;45(1):56-66.
6
Trends in development and approval times for new therapeutics in the United States.
Nat Rev Drug Discov. 2003 Sep;2(9):695-702. doi: 10.1038/nrd1178.
7
Drug product equivalence--are specifications necessary?
J Am Pharm Assoc. 1972 Jan;12(1):21-5.
9
Biomarker development, commercialization, and regulation: individualization of medicine lost in translation.
Clin Pharmacol Ther. 2007 Feb;81(2):153-5. doi: 10.1038/sj.clpt.6100088.

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验