The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop

被引：44

作者：

Manolis, E. ^{[1
]}

Rohou, S. ^{[2
]}

Hemmings, R. ^{[1
,3
]}

Salmonson, T. ^{[1
,4
]}

Karlsson, M. ^{[5
]}

Milligan, P. A. ^{[6
]}

机构：

[1] European Med Agcy, London, England

[2] AstraZeneca R&D, Global Med Dev, Regulatory Affairs, London, England

[3] Med & Healthcare Prod Regulatory Agcy, London, England

[4] Swedish Med Prod Agcy MPA, Uppsala, Sweden

[5] Uppsala Univ, Dept Pharmaceut Biosci, Uppsala, Sweden

[6] Global Clin Pharmacol, Pfizer Pharmacometr, Sandwich, Kent, England

来源：

CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY | 2013年 / 2卷 / 02期

关键词：

D O I：

10.1038/psp.2013.7

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The European Medicines Agency (EMA) and the Federation of Pharmaceutical Industries and Associations (EFPIA) hosted a workshop on modeling and simulation (M&S). 1 Representatives from industry, academia, and regulatory agencies from Europe and beyond discussed the role of M&S in the development and registration of medicinal products within plenary and breakout sessions (BOS). This manuscript summarizes the plenary discussion (Table 1) focusing on the European perspective. Deliverables from each BOS are included in separate papers.

引用

页数：4

共 9 条

[1] [Anonymous], 2012, EMA DRAFT CONC PAP E
[2] Arrowsmith J., 2011, NAT REV DRUG DISCOV
[3] Extrapolation of Adult Data and Other Data in Pediatric Drug-Development Programs
Dunne, Julia
Rodriguez, William J.
Murphy, Dianne
Beasley, B. Nhi
Burckart, Gilbert J.
Filie, Jane D.
Lewis, Linda L.
Sachs, Hari C.
Sheridan, Philip H.
Starke, Peter
Yao, Lynne P.
[J]. PEDIATRICS, 2011, 128 (05) : E1242 - E1249
[4] European Medicines Agency, EUR MED AG EUR FED P
[5] Kowalski KG, 2007, BIOPHARM REP, V15, P2
[6] Pharmacometrics for Regulatory Decision Making Status and Perspective
Manolis, Efthymios
Herold, Ralf
[J]. CLINICAL PHARMACOKINETICS, 2011, 50 (10) : 625 - 626
[7] Proposals for model-based paediatric medicinal development within the current European Union regulatory framework
Manolis, Efthymios
Pons, Gerard
[J]. BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2009, 68 (04) : 493 - 501
[8] The productivity crisis in pharmaceutical R&D
Pammolli, Fabio
Magazzini, Laura
Riccaboni, Massimo
[J]. NATURE REVIEWS DRUG DISCOVERY, 2011, 10 (06) : 428 - 438
[9] van der Graaf Piet H, 2012, CPT Pharmacometrics Syst Pharmacol, V1, pe8, DOI 10.1038/psp.2012.8

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