Smithers Viscient, a global leader in environmental, toxicology, and consumer safety testing for the crop protection, pharmaceutical, industrial chemical, and consumer product industries, announced that Smithers toxicology experts, Dr. Shakil Saghir and Dr. Michael Dorato, have authored a paper concerning extended one generation reproductive toxicity studies (EOGRTS). The paper, titled “Reproductive and Developmental Toxicity Testing: Examination of the Extended One-Generation Reproductive Toxicity Study Guideline,” is published in Regulatory Toxicology and Pharmacology, the official journal of the International Society of Regulatory Toxicology and Pharmacology (ISRTP). The paper is available with open access here.
The purpose of the paper is to provide further thoughts on addressing issues associated with the Extended One-Generation Reproductive Toxicity Study. The paper by Drs. Saghir and Dorato provides insight into the EOGRTS and suggests improvements for dose selection and monitoring systemic dose at multiple life-stages for better understanding of human relevance and sound interpretation of study data.
“The EOGRTS presents a different approach for those performing reproductive toxicity studies; however, it is a complex approach with many variables,” said Dr. Saghir. “Through our research experience, both in terms of performing highly complex toxicity studies as well as our expertise in determining kinetically-derived maximum dose (KMD), we have proposed a method for ascertaining the KMD for these studies, leading to the production of more useful study data.”
The performance of an EOGRTS represents a significant investment of money, capital and time for organizations. While utilizing the KMD approach discussed in the paper adds a new layer of complexity, it is an important step as it serves to ensure the selection of doses relevant for human health risk assessment. This approach will improve the cost-effectiveness of the study investment and help organizations avoid additional costs in conducting mode-of-action studies determining mechanism of effects observed only at kinetically nonlinear (non-relevant) doses.
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About Smithers Viscient
Smithers Viscient is a global Contract Research Organization (CRO) providing environmental testing, toxicology, and regulatory services for the crop protection, seed technology, pharmaceutical, industrial chemical, and the consumer and household product industries. With laboratories located in North America and Europe, Smithers Viscient has performed standard guideline and higher-tiered environmental studies for over 45 years. Smithers Viscient conducts studies to satisfy all regulatory requirements globally. Services include mammalian toxicology, ecotoxicology, avian toxicology, environmental fate, metabolism and residue, analytical, and product chemistry. For more information, go to: www.smithersviscient.com
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Last updated on: 25/08/2016
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