Intra-Target Microdosing (ITM): A Novel Drug Development Approach Aimed at Enabling Safer and Earlier Translation of Biological Insights Into Human Testing-Reference-Cited by-同舟云学术

Intra-Target Microdosing (ITM): A Novel Drug Development Approach Aimed at Enabling Safer and Earlier Translation of Biological Insights Into Human Testing

Published:2017-04-18 Issue:5 Volume:10 Page:337-350
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clinical And Translational Science

Author:

Burt T¹,Noveck RJ²,MacLeod DB³,Layton AT⁴,Rowland M⁵,Lappin G⁶

Affiliation:

1. Burt Consultancy; LLC; Durham North Carolina USA

2. Medical Director; Duke Clinical Research Unit; Durham North Carolina USA

3. Department of Anesthesiology; Duke University; Durham North Carolina USA

4. Robert R. and Katherine B. Penn Professor of Mathematics Arts and Sciences Council Chair Professor of Biomedical Engineering; Duke University; Durham North Carolina USA

5. School of Pharmacy and Pharmaceutical Sciences; University of Manchester; Manchester UK

6. Reader in Pharmaceutical Science; Lincoln School of Pharmacy; University of Lincoln; Lincoln Lincolnshire UK

Funder

National Institutes of Health

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/cts.12464/fullpdf

Reference87 articles.

1. Microdosing and other phase 0 Clinical Trials: Facilitating Translation in Drug Development;Burt;Clin. Transl. Sci.,2016

2. Reengineering translational science: the time is right;Collins;Sci. Transl. Med.,2011

3. The price of innovation: new estimates of drug development costs;DiMasi;J. Health Econ.,2003

4. FDA Innovation or stagnation: challenge and opportunity on the critical path to new medical products http://wwwfdagov/oc/initiatives/criticalpath/whitepaperhtml 2004

5. Rowland , M. Microdosing and the 3Rs

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