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Use of partial area under the curve metrics to assess bioequivalence of methylphenidate multiphasic modified release formulations.

作者信息

Stier Ethan M, Davit Barbara M, Chandaroy Parthapratim, Chen Mei-Ling, Fourie-Zirkelbach Jeanne, Jackson Andre, Kim Stephanie, Lionberger Robert, Mehta Mehul, Uppoor Ramana S, Wang Yaning, Yu Lawrence, Conner Dale P

机构信息

Division of Bioequivalence, Office of Generic Drugs, Food and Drug Administration, 7520 Standish Place MPNI, Rockville, MF 20855 Maryland, USA.

出版信息

AAPS J. 2012 Dec;14(4):925-6. doi: 10.1208/s12248-012-9397-7. Epub 2012 Sep 14.

DOI:10.1208/s12248-012-9397-7
PMID:22976173
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3475859/
Abstract
摘要

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本文引用的文献

1
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.
2
Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified release products: workshop summary report.建立确保缓控释产品治疗等效性的科学和监管标准的挑战和机遇：研讨会总结报告。
AAPS J. 2010 Sep;12(3):371-7. doi: 10.1208/s12248-010-9201-5. Epub 2010 May 4.
3
A comparison of once-daily extended-release methylphenidate formulations in children with attention-deficit/hyperactivity disorder in the laboratory school (the Comacs Study).实验室学校中患有注意力缺陷/多动障碍儿童使用每日一次缓释哌甲酯制剂的比较（Comacs研究）
Pediatrics. 2004 Mar;113(3 Pt 1):e206-16. doi: 10.1542/peds.113.3.e206.
4
Time-response analysis of the effect of stimulant medication on the learning ability of children referred for hyperactivity.兴奋剂药物对被转诊的多动症儿童学习能力影响的时间反应分析
Pediatrics. 1978 Jan;61(1):21-9.