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AAPS J. 2016 Nov;18(6):1373-1378. Epub 2016 Aug 1.

Nanomedicines: From Bench to Bedside and Beyond.

Author information

1
Phytoption LLC, West Lafayette, Indiana, USA. havelh@gmail.com.
2
Pfizer, Inc., Groton, Connecticut, USA.
3
Cerulean Pharma, Waltham, Massachusetts, USA.
4
BIND Therapeutics, Cambridge, Massachusetts, USA.
5
NanoCarrier Co. Ltd., Kashiwa, Japan.
6
Amgen, Inc., Cambridge, Massachusetts, USA.
7
Drinker Biddle & Reath, Washington, District of Columbia, USA.

Abstract

Advancing nanomedicines from concept to clinic requires integration of new science with traditional pharmaceutical development. The medical and commercial success of nanomedicines is greatly facilitated when those charged with developing nanomedicines are cognizant of the unique opportunities and technical challenges that these products present. These individuals must also be knowledgeable about the processes of clinical and product development, including regulatory considerations, to maximize the odds for successful product registration. This article outlines these topics with a goal to accelerate the combination of academic innovation with collaborative industrial scientists who understand pharmaceutical development and regulatory approval requirements-only together can they realize the full potential of nanomedicines for patients.

KEYWORDS:

ADME; CMC; PK/PD; academic-industrial collaboration; biodistribution; oncology; preclinical; quality by design; targeted delivery; toxicology

PMID:
27480318
DOI:
10.1208/s12248-016-9961-7
[Indexed for MEDLINE]

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