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The cutoff time point of the partial area method for assessment of rate of absorption in bioequivalence studies.

作者信息

Macheras P, Symillides M, Reppas C

机构信息

Department of Pharmacy, University of Athens, Panepistimiopolis, Greece.

出版信息

Pharm Res. 1994 Jun;11(6):831-4. doi: 10.1023/a:1018921622981.

DOI:10.1023/a:1018921622981
PMID:7937521
Abstract

The partial area method has been suggested for the assessment of the absorption rate in bioequivalence studies. This paper provides a theoretical basis for the estimation of the optimal cutoff time point of the partial areas for drugs with one compartment model disposition. The analysis is performed by using the appropriate equations which relate the normalized (in terms of the extent of absorption) partial areas with time expressed in terms of multiples of half-life. Provided that the quality of experimental data ensures precise estimation of the parameters, the tmax of the formulation with the faster absorption characteristics is generally the most practical cutoff time point for calculation of the normalized partial areas, when a drug follows one compartment model disposition with linear absorption.

摘要

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本文引用的文献

1
Estimation of absorption rate constant in a one-compartment model with the profile of the bioavailable dose eliminated as a function of multiples of half-life.
J Pharm Sci. 1993 Dec;82(12):1298-300. doi: 10.1002/jps.2600821226.
2
Evaluation of different indirect measures of rate of drug absorption in comparative pharmacokinetic studies.在比较药代动力学研究中对不同药物吸收速率间接测量方法的评估。
J Pharm Sci. 1994 Feb;83(2):212-5. doi: 10.1002/jps.2600830219.
3
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。
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
Use of partial AUC (PAUC) to evaluate bioequivalence--a case study with complex absorption: methylphenidate.应用部分 AUC(PAUC)评估生物等效性——以复杂吸收为特征的案例研究:哌醋甲酯。
Pharm Res. 2013 Jan;30(1):191-202. doi: 10.1007/s11095-012-0862-x. Epub 2012 Sep 25.
5
Metrics for the evaluation of bioequivalence of modified-release formulations.用于评价缓释制剂生物等效性的指标。
AAPS J. 2012 Dec;14(4):813-9. doi: 10.1208/s12248-012-9396-8. Epub 2012 Aug 22.
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An in vitro methodology for forecasting luminal concentrations and precipitation of highly permeable lipophilic weak bases in the fasted upper small intestine.一种用于预测空腹上小肠中高渗透性亲脂性弱碱的腔内浓度和沉淀的体外方法。
Pharm Res. 2012 Dec;29(12):3486-98. doi: 10.1007/s11095-012-0844-z. Epub 2012 Aug 14.
7
Using partial area for evaluation of bioavailability and bioequivalence.利用部分面积评估生物利用度和生物等效性。
Pharm Res. 2011 Aug;28(8):1939-47. doi: 10.1007/s11095-011-0421-x. Epub 2011 Apr 13.
8
Measures of exposure versus measures of rate and extent of absorption.暴露量度与吸收速率及吸收程度量度
Clin Pharmacokinet. 2001;40(8):565-72. doi: 10.2165/00003088-200140080-00001.
9
Evaluation of truncated areas in the assessment of bioequivalence of immediate release formulations of drugs with long half-lives and of Cmax with different dissolution rates.在评估具有长半衰期的速释制剂的生物等效性以及不同溶出速率的Cmax时对截短面积的评估。
Pharm Res. 1999 Jun;16(6):939-43. doi: 10.1023/a:1018898624643.
10
The duration of measuring partial AUCs for the assessment of bioequivalence.用于评估生物等效性的部分AUC测量持续时间。
Pharm Res. 1998 Mar;15(3):399-404. doi: 10.1023/a:1011916113082.
Int J Clin Pharmacol Ther Toxicol. 1991 Oct;29(10):394-9.
4
An alternative approach for assessment of rate of absorption in bioequivalence studies.生物等效性研究中吸收速率评估的另一种方法。
Pharm Res. 1992 Nov;9(11):1380-5. doi: 10.1023/a:1015842425553.