生物等效性研究中的争议 - Suppr

Suppr

超能文献

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

相似文献

Controversies in bioequivalence studies.生物等效性研究中的争议

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

What are narrow therapeutic index drugs?

Clin Pharmacol Ther. 1998 May;63(5):501-5. doi: 10.1016/S0009-9236(98)90100-X.

Mean difference vs. variability reduction: tradeoffs in aggregate measures for individual bioequivalence. FDA Individual Bioequivalence Working Group.平均差异与变异性降低：个体生物等效性总体测量中的权衡。美国食品药品监督管理局个体生物等效性工作组

Int J Clin Pharmacol Ther. 1996 Dec;34(12):535-41.

Bioavailability and bioequivalence requirements: abbreviated applications. Final Rule.生物利用度和生物等效性要求：简略申请。最终规则。

Fed Regist. 2002 Dec 19;67(244):77668-75.

Bioavailability and bioequivalence.生物利用度与生物等效性。

J Clin Pharmacol. 1976 Oct;16(10 Pt 2):539-45. doi: 10.1177/009127007601601013.

Bioavailability and bioequivalence trials: statistics & pharmacokinetic principles.生物利用度与生物等效性试验：统计学与药代动力学原理

Stud Health Technol Inform. 2004;103:159-79.

The basis for individual bioequivalence. FDA Population and Individual Bioequivalence Working Group.个体生物等效性的基础。美国食品药品监督管理局群体与个体生物等效性工作组。

Eur J Drug Metab Pharmacokinet. 2000 Jan-Mar;25(1):13-7. doi: 10.1007/BF03190050.

Aspects for bioavailability and bioequivalence revision: possible implications on clinical pharmacology.

Methods Find Exp Clin Pharmacol. 1987 Jul;9(7):453-9.

Review of the 1993 Veterinary Drug Bioequivalence Workshop, held on March 29-31, 1993, in Rockville, Maryland.1993年兽药生物等效性研讨会综述，该研讨会于1993年3月29日至31日在马里兰州罗克维尔举行。

J Vet Pharmacol Ther. 1994 Apr;17(2):85-119.

The 2nd Calibration and Validation Group workshop on recent issues in good laboratory practice bioanalysis.第二届良好实验室规范生物分析近期问题校准与验证小组研讨会

Bioanalysis. 2009 Apr;1(1):19-30. doi: 10.4155/bio.09.11.

引用本文的文献

A Model for Predicting the Interindividual Variability of Drug-Drug Interactions.一种预测药物相互作用个体间变异性的模型。

AAPS J. 2017 Mar;19(2):497-509. doi: 10.1208/s12248-016-0021-0. Epub 2016 Dec 6.

Individualizing therapy - in search of approaches to maximize the benefit of drug treatment (II).个体化治疗——探寻最大化药物治疗益处的方法（二）

Curr Control Trials Cardiovasc Med. 2004 Aug 16;5(1):7. doi: 10.1186/1468-6708-5-7.

Multiplicative dependence of the first order rate constant and its impact on clinical pharmacokinetics and bioequivalence.

Eur J Drug Metab Pharmacokinet. 2004 Jan-Mar;29(1):43-9. doi: 10.1007/BF03190573.

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.

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.

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.

Pharmacokinetics of a new oral formulation of amoxicillin.

Eur J Drug Metab Pharmacokinet. 1997 Jan-Mar;22(1):47-52. doi: 10.1007/BF03189784.

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.

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.

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.

本文引用的文献

Pharmacokinetic determinants in the design and evaluation of sustained-release dosage forms.药代动力学决定因素在缓释制剂设计和评价中的应用。

Pharm Res. 1984 Mar;1(2):82-8. doi: 10.1023/A:1016355431740.

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.

An exact confidence interval from untransformed data for the ratio of two formulation means.

J Pharmacokinet Biopharm. 1984 Dec;12(6):649-55. doi: 10.1007/BF01059558.

Pharmacokinetic criteria for the evaluation of retard formulations.

Eur J Clin Pharmacol. 1974 Oct 4;7(6):429-32. doi: 10.1007/BF00560355.

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.

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.

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.

A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability.两种单侧检验方法与评估平均生物利用度等效性的效能法的比较。

J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.

Theophylline steady-state pharmacokinetics: recent concepts and their application in chronotherapy of reactive airway diseases.茶碱稳态药代动力学：最新概念及其在反应性气道疾病时辰治疗中的应用。

Chronobiol Int. 1987;4(3):331-47. doi: 10.3109/07420528709083523.

Galenical development of a new sustained-release theophylline pellet formulation for once-daily administration.一种用于每日一次给药的新型缓释茶碱微丸制剂的药剂学开发。

Arzneimittelforschung. 1988 Aug;38(8A):1203-9.

文献AI研究员

20分钟写一篇综述，助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型，支持多种主流文档格式。

立即体验