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Individual bioequivalence. New concepts in the statistical assessment of bioequivalence metrics. FDA Individual Bioequivalence Working Group.

作者信息

Patnaik R N, Lesko L J, Chen M L, Williams R L

机构信息

Division of Bioequivalence, Food and Drug Administration, Rockville, Maryland, USA.

出版信息

Clin Pharmacokinet. 1997 Jul;33(1):1-6. doi: 10.2165/00003088-199733010-00001.

DOI:10.2165/00003088-199733010-00001
PMID:9250419
Abstract
摘要

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Int J Clin Pharmacol Ther. 1996 Dec;34(12):535-41.
2
The assessment of individual and population bioequivalence.
J Biopharm Stat. 1996 Mar;6(1):1-14. doi: 10.1080/10543409608835118.
3
On population and individual bioequivalence.论群体生物等效性与个体生物等效性
Bioequivalence for highly variable drugs: regulatory agreements, disagreements, and harmonization.高变异药物的生物等效性：监管协议、分歧和协调。
J Pharmacokinet Pharmacodyn. 2019 Apr;46(2):117-126. doi: 10.1007/s10928-019-09623-w. Epub 2019 Feb 23.
4
Use of Therapeutic Drug Monitoring, Electronic Health Record Data, and Pharmacokinetic Modeling to Determine the Therapeutic Index of Phenytoin and Lamotrigine.利用治疗药物监测、电子健康记录数据和药代动力学模型来确定苯妥英钠和拉莫三嗪的治疗指数。
Ther Drug Monit. 2016 Dec;38(6):728-737. doi: 10.1097/FTD.0000000000000354.
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Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products of agomelatine in Chinese subjects.在中国受试者中对阿戈美拉汀高变异仿制药实施参考标度平均生物等效性方法。
Acta Pharm Sin B. 2016 Jan;6(1):71-8. doi: 10.1016/j.apsb.2015.10.003. Epub 2015 Nov 17.
6
Bioequivalence and Bioavailability Clinical Trials: A Status Report from the National Institutes of Health ClinicalTrials.gov Registry.生物等效性与生物利用度临床试验：来自美国国立卫生研究院临床试验.gov注册库的状态报告
J Bioequivalence Bioavailab. 2013 Nov 4;5:244-247. doi: 10.4172/jbb.1000167.
7
Inflation of the type I error: investigations on regulatory recommendations for bioequivalence of highly variable drugs.I 型错误的放大：关于高变异药物生物等效性监管建议的调查
Pharm Res. 2015 Jan;32(1):135-43. doi: 10.1007/s11095-014-1450-z. Epub 2014 Jul 18.
8
Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration.美国食品和药物管理局实施参照标度平均生物等效性方法评估高度变异仿制药产品。
AAPS J. 2012 Dec;14(4):915-24. doi: 10.1208/s12248-012-9406-x. Epub 2012 Sep 13.
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Bioequivalence of highly variable drugs: a comparison of the newly proposed regulatory approaches by FDA and EMA.高度变异药物的生物等效性：FDA 和 EMA 新提出的监管方法比较。
Pharm Res. 2012 Apr;29(4):1066-77. doi: 10.1007/s11095-011-0651-y. Epub 2011 Dec 28.
10
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J Biopharm Stat. 1994 Mar;4(1):39-52. doi: 10.1080/10543409408835071.
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Int J Clin Pharmacol Ther. 1994 Sep;32(9):497-508.
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Biometrics. 1995 Jun;51(2):615-26.
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J Pharmacokinet Biopharm. 1990 Jun;18(3):259-73. doi: 10.1007/BF01062202.