Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations

被引：19

作者：

Stier, Ethan M. ^{[1
]}

Davit, Barbara M. ^{[1
]}

Chandaroy, Parthapratim ^{[1
]}

Chen, Mei-Ling ^{[2
]}

Fourie-Zirkelbach, Jeanne ^{[3
]}

Jackson, Andre ^{[3
]}

Kim, Stephanie

Lionberger, Robert

Mehta, Mehul ^{[3
]}

Uppoor, Ramana S. ^{[3
]}

Wang, Yaning ^{[3
]}

Yu, Lawrence

Conner, Dale P. ^{[1
]}

机构：

[1] US FDA, Div Bioequivalence, Off Gener Drugs, Rockville, MD 20855 USA

[2] US FDA, Off Pharmaceut Sci, Silver Spring, MD USA

[3] US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA

来源：

AAPS JOURNAL | 2012年 / 14卷 / 04期

关键词：

attention deficit hyperactivity disorder; bioequivalence; generic drugs; methylphenidate; pAUC; CHILDREN;

D O I：

10.1208/s12248-012-9397-7

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

[No abstract available]

引用

页码：925 / 926

页数：2

共 7 条

[1]

[Anonymous], 2010, M ADV COMM PHARM SCI

[2]

[Anonymous], FDA M ADV COMM PHARM

[3] Using Partial Area for Evaluation of Bioavailability and Bioequivalence [J].

Chen, Mei-Ling ;

Davit, Barbara ;

Lionberger, Robert ;

Wahba, Zakaria ;

Ahn, Hae-Young ;

Yu, Lawrence X. .

PHARMACEUTICAL RESEARCH, 2011, 28 (08) :1939-1947

[4]

Chen ML, 2010, AAPS J, V12, P371, DOI DOI 10.1208/S12248-010-9201-5

[5]

SWANSON J, 1978, PEDIATRICS, V61, P21

[6] A comparison of once-daily extended-release methylphenidate formulations in children with attention-deficit/hyperactivity disorder in the laboratory school (The COMACS study) [J].

Swanson, JM ;

Wigal, SB ;

Wigal, T ;

Sonuga-Barke, EJS ;

Greenhill, LL ;

Biederman, J ;

Kollins, S ;

Nguyen, AS ;

DeCory, HH ;

Dirksen, SJH ;

Hatch, SJ .

PEDIATRICS, 2004, 113 (03) :E206-E216

[7]

U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research (CDER), GUID IND BIOAV BIOEQ

← 1 →