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PMID: 17915830 Published · epublish English Journal Article Review

Biomarkers, metabonomics, and drug development: can inborn errors of metabolism help in understanding drug toxicity?

The AAPS journal ·Vol. 9 ·No. 3 ·2007-07-20 ·Pages E284-97

Vangala S, Tonelli A

Abstract

Application of "omics" technology during drug discovery and development is rapidly evolving. This review evaluates the current status and future role of "metabonomics" as a tool in the drug development process to reduce the safety-related attrition rates and bridge the gaps between preclinical and clinical, and clinical and market. Particularly, the review looks at the knowledge gap between the pharmaceutical industry and pediatric hospitals, where metabonomics has been successfully applied to screen and treat newborn babies with inborn errors of metabolism. An attempt has been made to relate the clinical pathology associated with inborn errors of metabolism with those of drug-induced pathology. It is proposed that extending the metabonomic biomarkers used in pediatric hospitals, as "advanced clinical chemistry" for preclinical and clinical drug development, is immediately warranted for better safety assessment of drug candidates. The latest advances in mass spectrometry and nuclear magnetic resonance (NMR) spectroscopy should help replace the traditional approaches of laboratory clinical chemistry and move the safety evaluation of drug candidates into the new millennium.

MeSH Terms
Biomarkers Drug-Related Side Effects and Adverse Reactions Enzymes/deficiency Humans Metabolism/physiology Metabolism, Inborn Errors/drug therapy,enzymology
Chemicals
Biomarkers Enzymes
Authors & Affiliations
2 authors, click to expand affiliations / ORCID
Vangala Subrahmanyam
Global Preclinical Development, Johnson & Johnson Pharmaceutical Research and Development, Raritan, NJ, USA. [email protected]
Tonelli Alfred
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Article Info
Journal
The AAPS journal
Abbr.
AAPS J
ISSN
1550-7416
DOI
10.1208/aapsj0903031
Email
[email protected]
Published
2007-07-20
Epub
2007-00-20
Pages
E284-97
Language
English
Region
United States
NLM ID
101223209
PMCID
PMC2751476
Subset
IM
External Links
PubMed source DOI: 10.1208/aapsj0903031 PMC Full Text View journal details
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