Differences in reference products: dissolution and in vivo evidence.

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作者信息

McGilveray I J

机构信息

McGilveray Pharmacon Inc, Ottawa, Ontario Canada.

出版信息

Eur J Drug Metab Pharmacokinet. 2000 Jan-Mar;25(1):32-5. doi: 10.1007/BF03190054.

DOI:10.1007/BF03190054

PMID:11032087

Abstract

摘要

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Differences in reference products: dissolution and in vivo evidence.

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本文引用的文献

Typical variability in drug dissolution testing: study with USP and FDA calibrator tablets and a marketed drug (glibenclamide) product.药物溶出度测试中的典型变异性：使用美国药典（USP）和美国食品药品监督管理局（FDA）校准片以及一种市售药物（格列本脲）产品的研究

Eur J Pharm Sci. 1999 Feb;7(3):249-58. doi: 10.1016/s0928-0987(98)00034-7.

Simple bioequivalence criteria: are they relevant to critical dose drugs? Experience gained from cyclosporine.简单的生物等效性标准：它们与临界剂量药物相关吗？从环孢素获得的经验。

Ther Drug Monit. 1997 Aug;19(4):375-81. doi: 10.1097/00007691-199708000-00002.

Micronised fenofibrate.微粉化非诺贝特

Atherosclerosis. 1994 Oct;110 Suppl:S45-8. doi: 10.1016/0021-9150(94)05375-s.

A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability.生物药剂学药物分类的理论基础：体外药物溶出度与体内生物利用度的相关性。

Pharm Res. 1995 Mar;12(3):413-20. doi: 10.1023/a:1016212804288.

Outbreak of anticonvulsant intoxication in an Australian city.澳大利亚一座城市发生抗惊厥药物中毒事件。

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The objective and timing of drug disposition studies, appendix IV. Phenylbutazone formulations: in vitro dissolution and in vivo performance.药物处置研究的目的和时间安排，附录IV。保泰松制剂：体外溶出度和体内性能。

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Hospital admissions due to therapeutic overdosage with digoxin.因地高辛治疗过量导致的住院情况。

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