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相对于稳定同位素标记内标物的丙咪嗪片生物利用度:提高生物利用度测试的效能

Bioavailability of imipramine tablets relative to a stable isotope-labeled internal standard: increasing the power of bioavailability tests.

作者信息

Heck H A, Buttrill S E, Flynn N W, Dyer R L, Anbar M, Cairns T, Dighe S, Cabana B E

出版信息

J Pharmacokinet Biopharm. 1979 Jun;7(3):233-48. doi: 10.1007/BF01060015.

DOI:10.1007/BF01060015
PMID:480146
Abstract

A new methodology for comparative bioavailability testing is described in which each drug formulation is compared with a stable isotope-labeled variant of the drug that is consumed orally in solution at the same time the tested formulation is ingested. The methodology is used to determine the comparative bioavailabilities of two commercially available brands of imipramine hydrochloride. The power of the new methodology to detect differences between drug formulations, when, in fact, such differences exist, is shown to be superior to that of conventional bioavailability tests.

摘要

本文描述了一种用于比较生物利用度测试的新方法,其中每种药物制剂都与该药物的稳定同位素标记变体进行比较,该变体在摄入受试制剂的同时以溶液形式口服。该方法用于测定两种市售品牌盐酸丙咪嗪的相对生物利用度。结果表明,当药物制剂之间确实存在差异时,这种新方法检测差异的能力优于传统生物利用度测试。

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本文引用的文献

1
Use of confidence intervals in analysis of comparative bioavailability trials.置信区间在比较生物利用度试验分析中的应用。
J Pharm Sci. 1972 Aug;61(8):1340-1. doi: 10.1002/jps.2600610845.
2
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Biomed Mass Spectrom. 1978 Mar;5(3):250-7. doi: 10.1002/bms.1200050315.
通过铜(I)催化的氟化烯炔串联胺化/环化反应合成功能化氮杂环庚三烯
Molecules. 2022 Aug 15;27(16):5195. doi: 10.3390/molecules27165195.
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Reduction of imines with a reusable bimetallic PdCo-FeO catalyst at room temperature under atmospheric pressure of H.在氢气常压下,使用可重复使用的双金属PdCo-FeO催化剂在室温下还原亚胺。
RSC Adv. 2022 Jan 18;12(4):2436-2442. doi: 10.1039/d1ra08552b. eCollection 2022 Jan 12.
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The stable isotope method for determining absolute bioavailability.用于测定绝对生物利用度的稳定同位素法。
Transl Clin Pharmacol. 2017 Jun;25(2):53-58. doi: 10.12793/tcp.2017.25.2.53. Epub 2017 Jun 15.
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Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link-a Workshop Summary Report.建立体外-体内关联的溶解和转化建模策略——研讨会总结报告
AAPS J. 2019 Feb 11;21(2):29. doi: 10.1208/s12248-019-0298-x.
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Identification of novel macropinocytosis inhibitors using a rational screen of Food and Drug Administration-approved drugs.采用合理筛选美国食品和药物管理局批准药物的方法鉴定新型巨胞饮抑制剂。
Br J Pharmacol. 2018 Sep;175(18):3640-3655. doi: 10.1111/bph.14429. Epub 2018 Aug 1.
8
Re-introduction of a novel approach to the use of stable isotopes in pharmacokinetic studies.重新引入一种新方法,将稳定同位素应用于药代动力学研究。
AAPS J. 2012 Sep;14(3):639-45. doi: 10.1208/s12248-012-9371-4. Epub 2012 Jun 9.
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Pharm Res. 2012 Aug;29(8):2070-8. doi: 10.1007/s11095-012-0735-3. Epub 2012 Mar 16.
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