What is it about?
A simple formula is proposed to estimate teratogenic severity from summary data of each group within an embryo-fetal developmental (EFD) toxicity study. One use of the estimate is to assist in validation of teratogenic screening assays.
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Why is it important?
Screening assays for teratogenicity should be validated with compounds that have known teratogenic severity. The most consistent and well used assay to assess teratogenicity is the EFD study that is commonly conducted in rodents and/or rabbits. The overall teratogenic severity within a group of an EFD study ranges from none to severe. This paper takes summary EFD data, including maternal parameters of toxicity, to estimate a teratogenic severity score for each group. For validation the screening assays may compare their results to the scores generated from the EFD studies.
Perspectives
A given exogenous agent (e.g., a drug or chemical) should not be categorized as teratogenic. It is the dose or exposure of the agent in a sensitive species during a critical period of development that determines teratogenicity. An appropriate assay to assess teratogenic severity is the EFD study in rodents and/or rabbits. Each group within such studies will produce an overall result that range for none to severe teratogenicity. A formula was created to estimate teratogenic severity for each group in an EFD study. These scores should be used in validation of screening assays.
Dr L. David Wise
Read the Original
This page is a summary of: Numeric Estimates of Teratogenic Severity from Embryo-Fetal Developmental Toxicity Studies, Birth Defects Research Part B Developmental and Reproductive Toxicology, February 2016, Wiley,
DOI: 10.1002/bdrb.21171.
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