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Indian Journal of Pharmacology
Medknow Publications on behalf of Indian Pharmacological Society
ISSN: 0253-7613
EISSN: 0253-7613
Vol. 40, No. 6, 2008, pp. 240-242
Bioline Code: ph08069
Full paper language: English
Document type: Review Article
Document available free of charge

Indian Journal of Pharmacology, Vol. 40, No. 6, 2008, pp. 240-242

 en Phase 0 - Microdosing strategy in clinical trials
Naidu, M.U.R & Rani, P Usha

Abstract

Drug development is an activity that is long, complex and expensive. In 2004, attrition in the drug development paradigm prompted the US Food and Drug Administration (FDA) to introduce its ′Critical Path′ document, which highlighted the serious discordance between major scientific advances and limited drug development process. One issue addressed was that of microdosing. The concept of microdosing involves the use of extremely low, nonpharmacologically active doses of a drug to define the pharmacokinetic profile of the medication in human subjects. Microdosing, thus, appears as a new viable concept in the ′toolbox′ of the drug development activity. It appears that microdosing strategy could complement standard animal-to-human scaling, redefining the existing concept of phase I clinical research. In future, when research methods and technology involved in Phase 0 studies become more sophisticated, human microdosing may be applied to a number of drugs developed subsequently.

Keywords
Drug discovery and development, microdosing, phase 0

 
© Copyright 2008 Indian Journal of Pharmacology.
Alternative site location: http://www.ijp-online.com

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