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两种市售卡马西平片制剂的相对生物利用度

Comparative bioavailability of two commercial preparations of carbamazepine tablets.

作者信息

Anttila M, Kahela P, Panelius M, Yrjänä T, Tikkanen R, Aaltonen R

出版信息

Eur J Clin Pharmacol. 1979 Jul;15(6):421-5. doi: 10.1007/BF00561742.

DOI:10.1007/BF00561742
PMID:583039
Abstract

A comparative bioavailability study was performed using two commercially available types of carbamazepine tablets, by statistical analysis of serum levels and other bioavailability parameters. After single oral dose the extent of absorption from the two preparations was similar, although a statistically significant difference in absorption rates was observed. In a multiple-dose study no significant difference in serum carbamazepine levels was found, so the tablets could be considered as bioequivalent drug products.

摘要

通过对血清水平和其他生物利用度参数进行统计分析,使用两种市售类型的卡马西平片进行了一项生物利用度对比研究。单次口服给药后,两种制剂的吸收程度相似,尽管在吸收速率上观察到有统计学显著差异。在多剂量研究中,未发现血清卡马西平水平有显著差异,因此这些片剂可被视为生物等效的药品。

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1
Comparative bioavailability of two commercial preparations of carbamazepine tablets.两种市售卡马西平片制剂的相对生物利用度
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Exposure-response analysis reveals that clinically important toxicity difference can exist between bioequivalent carbamazepine tablets.

本文引用的文献

1
Serum concentration of carbamazepine: comparison of Herrmann's spectrophotometric method and a new GLC method for the determination of carbamazepine.卡马西平的血清浓度:赫尔曼分光光度法与一种新的气相色谱法测定卡马西平的比较
Epilepsia. 1976 Mar;17(1):67-72. doi: 10.1111/j.1528-1157.1976.tb03384.x.
2
Plasma kinetics of carbamazepine and its epoxide metabolite in man after single and multiple doses.卡马西平及其环氧化物代谢产物在人体单次和多次给药后的血浆动力学
Eur J Clin Pharmacol. 1975 Jun 13;8(5):337-41. doi: 10.1007/BF00562659.
3
Distribution and elimination kinetics of carbamazepine in man.
暴露-反应分析表明,生物等效的卡马西平片之间可能存在具有临床意义的毒性差异。
Br J Clin Pharmacol. 2008 Jan;65(1):110-22. doi: 10.1111/j.1365-2125.2007.02984.x. Epub 2007 Aug 15.
4
Statistical analysis of bioavailability studies: parametric and nonparametric confidence intervals.
Eur J Clin Pharmacol. 1983;24(1):127-36. doi: 10.1007/BF00613939.
卡马西平在人体内的分布与消除动力学
Eur J Clin Pharmacol. 1975 Feb 28;8(2):91-6. doi: 10.1007/BF00561556.
4
Bioavailability of two carbamazepine preparations during chronic administration to epileptic patients.两种卡马西平制剂在癫痫患者长期给药期间的生物利用度。
Epilepsia. 1975 Dec;16(5):759-64. doi: 10.1111/j.1528-1157.1975.tb04762.x.
5
Pharmacokinetics of carbamazepine in normal man.卡马西平在正常人体内的药代动力学。
Clin Pharmacol Ther. 1975 Jun;17(6):657-68. doi: 10.1002/cpt1975176657.
6
Pharmacokinetics of carbamazepine in normal humans after single and repeated oral doses.卡马西平单次及多次口服给药后在正常人体内的药代动力学
J Pharmacokinet Biopharm. 1976 Dec;4(6):521-35. doi: 10.1007/BF01064556.