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The AAPS Journal

, Volume 18, Issue 6, pp 1373–1378 | Cite as

Nanomedicines: From Bench to Bedside and Beyond

  • Henry HavelEmail author
  • Gregory Finch
  • Pamela Strode
  • Marc Wolfgang
  • Stephen Zale
  • Iulian Bobe
  • Hagop Youssoufian
  • Matthew Peterson
  • Maggie Liu
Review Article Theme: Nanotechnology in Complex Drug Products: Learning from the Past, Preparing for the Future
Part of the following topical collections:
  1. Theme: Nanotechnology in Complex Drug Products: Learning from the Past, Preparing for the Future

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.

Key words

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

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Copyright information

© American Association of Pharmaceutical Scientists 2016

Authors and Affiliations

  1. 1.Phytoption LLCWest LafayetteUSA
  2. 2.Pfizer, Inc.GrotonUSA
  3. 3.Cerulean PharmaWalthamUSA
  4. 4.BIND TherapeuticsCambridgeUSA
  5. 5.NanoCarrier Co. Ltd.KashiwaJapan
  6. 6.Amgen, Inc.CambridgeUSA
  7. 7.Drinker Biddle & ReathWashingtonUSA

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