Document Detail

Toward in vitro biomarkers for developmental toxicity and their extrapolation to the in vivo situation.
MedLine Citation:
PMID:  22114915     Owner:  NLM     Status:  MEDLINE    
INTRODUCTION: Reliable in vitro and in silico assays as alternatives for in vivo developmental toxicity studies are urgently needed, for the replacement, reduction and refinement (3Rs) of animal use in toxicological research. Therefore, relevant biomarkers for in vivo developmental toxicity in in vitro assays are needed.
AREAS COVERED: The present review gives an overview of alternative assays, as described in literature, for in vivo developmental toxicity, including the effects (readouts) assessed in these assays. The authors discuss how these data may be used to obtain relevant biomarkers for in vivo developmental toxicity, and how in vitro effect data can be translated to the in vivo situation using physiologically based kinetic (PBK) modeling.
EXPERT OPINION: Relevance of readouts in in vitro developmental toxicity assays as predictive biomarkers for in vivo developmental toxicity should be evaluated by comparing the obtained in vitro effect concentrations with in vivo internal concentrations at dose levels causing developmental toxicity. Extrapolation of the in vitro effect concentrations to in vivo dose levels using PBK modeling (i.e., reverse dosimetry) is promising in its use to derive points of departure for risk assessment, enabling the use of in vitro toxicity data in the safety assessment of compounds.
Jochem Louisse; Miriam Verwei; Ruud A Woutersen; Bas J Blaauboer; Ivonne M C M Rietjens
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Review     Date:  2011-11-25
Journal Detail:
Title:  Expert opinion on drug metabolism & toxicology     Volume:  8     ISSN:  1744-7607     ISO Abbreviation:  Expert Opin Drug Metab Toxicol     Publication Date:  2012 Jan 
Date Detail:
Created Date:  2011-12-22     Completed Date:  2012-09-17     Revised Date:  2013-11-06    
Medline Journal Info:
Nlm Unique ID:  101228422     Medline TA:  Expert Opin Drug Metab Toxicol     Country:  England    
Other Details:
Languages:  eng     Pagination:  11-27     Citation Subset:  IM    
Wageningen University, Division of Toxicology, Tuinlaan 5, 6703 HE Wageningen, The Netherlands.
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MeSH Terms
Biological Markers / metabolism
Embryonic Stem Cells / drug effects,  metabolism*
Pharmaceutical Preparations / adverse effects,  metabolism*
Risk Assessment
Toxicity Tests / methods*,  trends
Reg. No./Substance:
0/Biological Markers; 0/Pharmaceutical Preparations

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