Pharmacometrics for Regulatory Decision Making Status and Perspective

被引：15

作者：

Manolis, Efthymios ^{[1
]}

Herold, Ralf ^{[1
]}

机构：

[1] European Med Agcy, London E14 4HB, England

来源：

CLINICAL PHARMACOKINETICS | 2011年 / 50卷 / 10期

关键词：

Drug Development; European Medicine Agency; Population Pharmacokinetic Analysis; CHMP; Paediatric Committee;

D O I：

10.2165/11594340-000000000-00000

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

引用

页码：625 / 626

页数：2

共 11 条

[1]

*EUR MED AG, EMEACHMPSAWP72894200

[2]

*EUR MED AG, CHMPEWP14701304 EUR

[3]

*EUR MED AG, 2008, EMEA WORKSH MOD PAED

[4]

*EUR MED AG, EMEA1273182007

[5]

European Medicines Agency, EMACHMP376462009

[6]

European Medicines Agency, CPMPEWP56095 EUR MED

[7]

European Medicines Agency, CHMPEWP835612005 EUR

[8]

European Medicines Agency, CPMPICH271199 EUR ME

[9] Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions A Review of 198 Submissions Between 2000 and 2008 [J].

Lee, Joo Yeon ;

Garnett, Christine E. ;

Gobburu, Jogarao V. S. ;

Bhattaram, Venkatesh A. ;

Brar, Satjit ;

Earp, Justin C. ;

Jadhav, Pravin R. ;

Krudys, Kevin ;

Lesko, Lawrence J. ;

Li, Fang ;

Liu, Jiang ;

Madabushi, Rajnikanth ;

Marathe, Anshu ;

Mehrotra, Nitin ;

Tornoe, Christoffer ;

Wang, Yaning ;

Zhu, Hao .

CLINICAL PHARMACOKINETICS, 2011, 50 (10) :627-635

[10] Role of modeling and simulation in pediatric investigation plans [J].

Manolis, Efthymios ;

Osman, Tariq Eldirdiry ;

Herold, Ralf ;

Koenig, Franz ;

Tomasi, Paolo ;

Vamvakas, Spiros ;

Saint Raymond, Agnes .

PEDIATRIC ANESTHESIA, 2011, 21 (03) :214-221

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