Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development-Reference-Cited by-同舟云学术

Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development

Published:2016-03-30 Issue:2 Volume:9 Page:74-88
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clinical And Translational Science

Author:

Burt T¹,Yoshida K²³,Lappin G⁴,Vuong L⁵⁶,John C²,de Wildt SN⁷,Sugiyama Y⁸,Rowland M⁹¹⁰

Affiliation:

1. Principal; Burt Consultancy; Durham NC 27705 USA

2. Office of Clinical Pharmacology; Office of Translational Sciences; Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring MD USA

3. Oak Ridge Institution for Science and Education (ORISE) Fellow

4. Visiting Professor of Pharmacology School of Pharmacy University of Lincoln; Joseph Banks Laboratories; Lincoln LN6 7DL UK

5. Principal; LTV Consulting; Davis CA USA

6. Clinical Advisor at BioCore; Seoul South Korea

7. Intensive Care and Pediatric Surgery; Erasmus MC Sophia Children's Hospital; Rotterdam The Netherlands

8. Sugiyama Laboratory; RIKEN Innovation Center; RIKEN, 1-7-22 Suehiro-cho, Tsurumi-ku Yokohama Kanagawa 230-0045 Japan

9. Centre for Applied Pharmacokinetic Research; University of Manchester; Manchester M13 9PT UK

10. Department of Bioengineering and Therapeutic Sciences; University of California San Francisco; USA

Publisher

Wiley

Subject

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

Reference93 articles.

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3. ICH Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3(R2) International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use 8-16 ICH Secretariat Geneve, Switzerland 2009

4. Big physics, small doses: the use of AMS and PET in human microdosing of development drugs;Lappin;Nat. Rev. Drug Discov.,2003

5. Positron emission tomography microdosing: a new concept with application in tracer and early clinical drug development;Bergstrom;Eur. J. Clin. Pharmacol.,2003

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