• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

在生物等效性研究中,对于吸收速率而言,Cmax/AUC比Cmax是更清晰的衡量指标。

Cmax/AUC is a clearer measure than Cmax for absorption rates in investigations of bioequivalence.

作者信息

Endrenyi L, Fritsch S, Yan W

机构信息

University of Toronto, Department of Pharmacology, Ontario, Canada.

出版信息

Int J Clin Pharmacol Ther Toxicol. 1991 Oct;29(10):394-9.

PMID:1748540
Abstract

In bioequivalence studies, the maximum concentration (Cmax) is shown to reflect not only the rate but also the extent of absorption. Cmax is highly correlated with the area under the curve (AUC) contrasting blood concentration with time. Therefore, use of the Cmax/AUC ratio is recommended for assessing the equivalence of absorption rates. The ratio is independent of both intrasubject variations and possible differences in the extent of absorption and reflects only the contrast between the absorption and disposition rate constants (ka/k).

摘要

在生物等效性研究中,最大浓度(Cmax)不仅反映吸收速率,还反映吸收程度。Cmax与血药浓度-时间曲线下面积(AUC)高度相关。因此,建议使用Cmax/AUC比值来评估吸收速率的等效性。该比值不受个体内变异以及吸收程度可能存在的差异的影响,仅反映吸收速率常数与处置速率常数之间的对比(ka/k)。

相似文献

1
Cmax/AUC is a clearer measure than Cmax for absorption rates in investigations of bioequivalence.在生物等效性研究中,对于吸收速率而言,Cmax/AUC比Cmax是更清晰的衡量指标。
Int J Clin Pharmacol Ther Toxicol. 1991 Oct;29(10):394-9.
2
Choice of characteristics and their bioequivalence ranges for the comparison of absorption rates of immediate-release drug formulations.用于速释药物制剂吸收速率比较的特性选择及其生物等效性范围
Int J Clin Pharmacol Ther. 1994 Jul;32(7):323-8.
3
Variation of Cmax and Cmax/AUC in investigations of bioequivalence.生物等效性研究中Cmax和Cmax/AUC的变异
Int J Clin Pharmacol Ther Toxicol. 1993 Apr;31(4):184-9.
4
Comparison of absorption rates in bioequivalence studies of immediate release drug formulations.速释药物制剂生物等效性研究中吸收速率的比较。
Int J Clin Pharmacol Ther Toxicol. 1992 May;30(5):153-9.
5
Pharmacokinetic characteristics for extent of absorption and clearance in drug/drug interaction studies.药物/药物相互作用研究中吸收程度和清除率的药代动力学特征。
Int J Clin Pharmacol Ther. 1994 Dec;32(12):633-7.
6
Pharmacokinetic analysis of bioequivalence trials: implications for sex-related issues in clinical pharmacology and biopharmaceutics.生物等效性试验的药代动力学分析:对临床药理学和生物药剂学中性别相关问题的启示
Clin Pharmacol Ther. 2000 Nov;68(5):510-21. doi: 10.1067/mcp.2000.111184.
7
An area correction method to reduce intrasubject variability in bioequivalence studies.一种减少生物等效性研究中个体内变异性的区域校正方法。
J Pharm Pharm Sci. 1998 May-Aug;1(2):60-5.
8
A limited sampling approach in bioequivalence studies: application to long half-life drugs and replicate design studies.生物等效性研究中的有限采样法:在长半衰期药物及重复设计研究中的应用
Int J Clin Pharmacol Ther. 1999 Jun;37(6):275-81.
9
[Value of the theory of the optimal sampling scheme for bioequivalence studies].[生物等效性研究中最优抽样方案理论的价值]
Therapie. 1993 Jan-Feb;48(1):7-13.
10
Update on the statistical analysis of bioequivalence studies.生物等效性研究的统计分析最新进展。
Int J Clin Pharmacol Ther Toxicol. 1990 Mar;28(3):105-10.

引用本文的文献

1
The Finite Absorption Time Concept Guiding Model Informed Drug & Generics Development in Clinical Pharmacology.有限吸收时间概念指导模型助力临床药理学中药物及仿制药的研发。
Pharm Res. 2025 Jun 5. doi: 10.1007/s11095-025-03878-4.
2
Thalidomide-induced limb malformations: an update and reevaluation.沙利度胺所致肢体畸形:最新进展与重新评估
Arch Toxicol. 2025 May;99(5):1643-1747. doi: 10.1007/s00204-024-03930-z. Epub 2025 Apr 8.
3
Application of the Finite Absorption Time (F.A.T.) Concept in the Assessment of Bioequivalence.有限吸收时间(F.A.T.)概念在生物等效性评估中的应用。
Pharm Res. 2024 Jul;41(7):1413-1425. doi: 10.1007/s11095-024-03727-w. Epub 2024 Jun 19.
4
Evaluation of the antimalarial activity of SAM13-2HCl with morpholine amide (SKM13 derivative) against antimalarial drug-resistant Plasmodium falciparum and Plasmodium berghei infected ICR mice.评价具有吗啉酰胺(SKM13 衍生物)结构的 SAM13-2HCl 抗疟原虫活性对耐抗疟药物疟原虫和伯氏疟原虫感染 ICR 小鼠的影响。
Parasites Hosts Dis. 2024 Feb;62(1):42-52. doi: 10.3347/PHD.23093. Epub 2024 Feb 23.
5
Predictive Potential of BCS and Pharmacokinetic Parameters on Study Outcome: Analysis of 198 In Vivo Bioequivalence Studies.BCS 和药代动力学参数对研究结果的预测潜力:198 项体内生物等效性研究的分析。
Eur J Drug Metab Pharmacokinet. 2023 May;48(3):241-255. doi: 10.1007/s13318-023-00821-z. Epub 2023 Mar 5.
6
Evaluation of Excipient Risk in BCS Class I and III Biowaivers.BCS 分类 I 和 III 生物豁免辅料风险评估。
AAPS J. 2022 Jan 5;24(1):20. doi: 10.1208/s12248-021-00670-1.
7
Pharmacokinetic Behavior and Pharmacokinetic/Pharmacodynamic Integration of Danofloxacin Following Single or Co-Administration with Meloxicam in Healthy Lambs and Lambs with Respiratory Infections.单剂量或与美洛昔康联合给药后,达氟沙星在健康羔羊和患有呼吸道感染的羔羊体内的药代动力学行为及药代动力学/药效学整合
Antibiotics (Basel). 2021 Sep 30;10(10):1190. doi: 10.3390/antibiotics10101190.
8
Multivariate Assessment for Bioequivalence Based on the Correlation of Random Effect.基于随机效应相关性的生物等效性的多变量评估。
Drug Des Devel Ther. 2021 Aug 23;15:3675-3683. doi: 10.2147/DDDT.S318576. eCollection 2021.
9
Revising Pharmacokinetics of Oral Drug Absorption: II Bioavailability-Bioequivalence Considerations.修订口服药物吸收的药代动力学:二、生物利用度-生物等效性的考虑。
Pharm Res. 2021 Aug;38(8):1345-1356. doi: 10.1007/s11095-021-03078-w. Epub 2021 Aug 2.
10
Evaluation of the effects of atazanavir-ritonavir on the pharmacokinetics of lumefantrine in patients living with HIV in Lagos University Teaching Hospital, South-Western Nigeria.评价洛匹那韦利托那韦对尼日利亚拉各斯大学教学医院 HIV 感染者中盐酸左旋咪唑的药代动力学的影响。
Eur J Clin Pharmacol. 2021 Sep;77(9):1341-1348. doi: 10.1007/s00228-021-03116-x. Epub 2021 Mar 23.