Current Topics in Postnatal Behavioral Testing.
| Autor: | Henck JW; Toxicology Solutions Consulting LLC, Leeds, UT, USA judith.henck@yahoo.com., Elayan I; US Food and Drug Administration, Silver Spring, MD, USA., Vorhees C; Cincinnati Children's Research Foundation, Cincinnati, OH, USA., Fisher JE Jr; US Food and Drug Administration, Silver Spring, MD, USA., Morford LL; Eli Lilly and Co, Indianapolis, IN, USA. |
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| Jazyk: | angličtina |
| Zdroj: | International journal of toxicology [Int J Toxicol] 2016 Sep; Vol. 35 (5), pp. 499-520. Date of Electronic Publication: 2016 Jul 04. |
| DOI: | 10.1177/1091581816657082 |
| Abstrakt: | The study of developmental neurotoxicity (DNT) continues to be an important component of safety evaluation of candidate therapeutic agents and of industrial and environmental chemicals. Developmental neurotoxicity is considered to be an adverse change in the central and/or peripheral nervous system during development of an organism and has been primarily evaluated by studying functional outcomes, such as changes in behavior, neuropathology, neurochemistry, and/or neurophysiology. Neurobehavioral evaluations are a component of a wide range of toxicology studies in laboratory animal models, whereas neurochemistry and neurophysiology are less commonly employed. Although the primary focus of this article is on neurobehavioral evaluation in pre- and postnatal development and juvenile toxicology studies used in pharmaceutical development, concepts may also apply to adult nonclinical safety studies and Environmental Protection Agency/chemical assessments. This article summarizes the proceedings of a symposium held during the 2015 American College of Toxicology annual meeting and includes a discussion of the current status of DNT testing as well as potential issues and recommendations. Topics include the regulatory context for DNT testing; study design and interpretation; behavioral test selection, including a comparison of core learning and memory systems; age of testing; repeated testing of the same animals; use of alternative animal models; impact of findings; and extrapolation of animal results to humans. Integration of the regulatory experience and scientific concepts presented during this symposium, as well as from subsequent discussion and input, provides a synopsis of the current state of DNT testing in safety assessment, as well as a potential roadmap for future advancement. (© The Author(s) 2016.) |
| Databáze: | MEDLINE |
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