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Regulatory filing strategy for generic mesalazine modified release formulations.

作者信息

Gupta Sandeep K

机构信息

Clinical Pharmacologist, Ansal Palam Vihar, J-1044, First Floor, Gurgaon-122001, India.

出版信息

Indian J Pharmacol. 2011 Apr;43(2):221-2. doi: 10.4103/0253-7613.77386.

DOI:10.4103/0253-7613.77386
PMID:21572669
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3081473/
Abstract
摘要

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本文引用的文献

1
Multicentre randomized-controlled clinical trial of Ipocol, a new enteric-coated form of mesalazine, in comparison with Asacol in the treatment of ulcerative colitis.
Aliment Pharmacol Ther. 2005 May 1;21(9):1099-104. doi: 10.1111/j.1365-2036.2005.02442.x.
2
Review article: Oral, modified-release mesalazine formulations--proprietary versus generic.综述文章：口服缓释美沙拉嗪制剂——专利药与仿制药对比
Aliment Pharmacol Ther. 2003 May 15;17(10):1207-14. doi: 10.1046/j.1365-2036.2003.01578.x.
3
Bioequivalence testing for locally acting gastrointestinal products: what role for gamma scintigraphy?局部作用胃肠道产品的生物等效性测试：γ闪烁显像法有何作用？
J Clin Pharmacol. 2002 Nov;42(11):1200-10. doi: 10.1177/009127002762491280.