On firm ground: IP protection of therapeutic nanoparticles

被引：64

作者：

Burgess, Paul ^{[1
]}

Hutt, Peter Barton ^{[2
]}

Farokhzad, Omid C. ^{[3
,4
]}

Langer, Robert ^{[5
]}

Minick, Scott ^{[1
]}

Zale, Stephen ^{[1
]}

机构：

[1] BIND Biosci, Cambridge, MA USA

[2] Covington & Burling Associates, Washington, DC USA

[3] Brigham & Womens Hosp, Boston, MA 02115 USA

[4] Harvard Univ, Sch Med, Boston, MA USA

[5] MIT, Cambridge, MA 02139 USA

来源：

关键词：

D O I：

10.1038/nbt.1725

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

The development of generic therapeutic nanoparticles faces a combination of scientific, patent and regulatory challenges.

引用

页码：1267 / 1271

页数：5

共 7 条

[1]

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Farokhzad, Omid C. ;

Langer, Robert .

[3]

FDA Guidance for Industry, 2003, BIOAV BIOEQ STUD OR

[4]

*ORTH PROD LP, 2008, DOX PROD INF

[5]

U. S. Food and Drug Administration Department of Health and Human Services Office of Generic Drugs, 2010, DRAFT GUID DOX HYDR

[6]

*US FDA, 2007, CRIT PATH OPP GEN DR

[7]

US Food & Drug Administration, Orange book: Approved drug products with therapeutic equivalence evaluations