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Controversies in bioequivalence studies.

作者信息

Steinijans V W, Hauschke D, Jonkman J H

机构信息

Department of Biometry, Byk Gulden Pharmaceuticals, Konstanz, Germany.

出版信息

Clin Pharmacokinet. 1992 Apr;22(4):247-53. doi: 10.2165/00003088-199222040-00001.

DOI:10.2165/00003088-199222040-00001
PMID:1606785
Abstract
摘要

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本文引用的文献

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Pharm Res. 1984 Mar;1(2):82-8. doi: 10.1023/A:1016355431740.
2
Disposition and clinical pharmacokinetics of theophylline after administration of a new sustained release tablet.一种新型缓释片给药后茶碱的处置及临床药代动力学
Eur J Clin Pharmacol. 1981;21(1):39-44. doi: 10.1007/BF00609586.
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An exact confidence interval from untransformed data for the ratio of two formulation means.
Eur J Drug Metab Pharmacokinet. 2004 Jan-Mar;29(1):43-9. doi: 10.1007/BF03190573.
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Effects of food on clinical pharmacokinetics.食物对临床药代动力学的影响。
Clin Pharmacokinet. 1999 Sep;37(3):213-55. doi: 10.2165/00003088-199937030-00003.
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A study of the relative bioavailability of cysteamine hydrochloride, cysteamine bitartrate and phosphocysteamine in healthy adult male volunteers.一项关于盐酸半胱胺、酒石酸半胱胺和磷酸半胱胺在健康成年男性志愿者中的相对生物利用度的研究。
Br J Clin Pharmacol. 1999 Jan;47(1):49-52. doi: 10.1046/j.1365-2125.1999.00844.x.
6
Which bioequivalence study for a racemic drug? Application to milnacipran.外消旋药物的哪种生物等效性研究？米那普明的应用。
Eur J Drug Metab Pharmacokinet. 1998 Apr-Jun;23(2):166-71. doi: 10.1007/BF03189334.
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Pharmacokinetics of a new oral formulation of amoxicillin.
Eur J Drug Metab Pharmacokinet. 1997 Jan-Mar;22(1):47-52. doi: 10.1007/BF03189784.
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The influence of food on the absorption and metabolism of drugs: an update.食物对药物吸收和代谢的影响：最新进展
Eur J Drug Metab Pharmacokinet. 1996 Jul-Sep;21(3):201-11. doi: 10.1007/BF03189714.
9
Bioequivalence assessment of generic drugs: an American point of view.仿制药的生物等效性评估：美国视角
Eur J Drug Metab Pharmacokinet. 1996 Apr-Jun;21(2):159-64. doi: 10.1007/BF03190265.
10
Pharmacokinetics and pharmacodynamics of a single dose of recombinant human growth hormone after subcutaneous administration by jet-injection: comparison with conventional needle-injection.单次皮下喷射注射重组人生长激素后的药代动力学和药效学：与传统皮下注射的比较
Eur J Clin Pharmacol. 1995;49(1-2):69-72. doi: 10.1007/BF00192361.
J Pharmacokinet Biopharm. 1984 Dec;12(6):649-55. doi: 10.1007/BF01059558.
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Pharmacokinetic criteria for the evaluation of retard formulations.
Eur J Clin Pharmacol. 1974 Oct 4;7(6):429-32. doi: 10.1007/BF00560355.
5
Food-induced changes in theophylline absorption from controlled-release formulations. Part II. Importance of meal composition and dosing time relative to meal intake in assessing changes in absorption.食物对控释制剂中茶碱吸收的影响。第二部分。进餐成分和给药时间相对于进餐摄入时间在评估吸收变化中的重要性。
Clin Pharmacol Ther. 1985 Dec;38(6):642-7. doi: 10.1038/clpt.1985.238.
6
Food-induced changes in theophylline absorption from controlled-release formulations. Part I. Substantial increased and decreased absorption with Uniphyl tablets and Theo-Dur Sprinkle.食物对控释制剂中茶碱吸收的影响。第一部分。优喘平片和茶喘平胶囊吸收的显著增加和减少。
Clin Pharmacol Ther. 1985 Jul;38(1):77-83. doi: 10.1038/clpt.1985.138.
7
Effect of drug intake prior to or after meals on serum theophylline concentrations: single-dose studies with Euphylong.
Int J Clin Pharmacol Ther Toxicol. 1987 Apr;25(4):222-8.
8
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Arzneimittelforschung. 1988 Aug;38(8A):1203-9.