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Showing results 305 - 320 of 91813 for .

Showing results 305 - 320 of 91813 for .

Predose Phase Echocardiography Assessments for Canine Toxicology Studies: Are Two Better Than One?
ACT 2016 -- A leading cause of attrition during clinical trials or market withdrawal continues to be cardiovascular toxicity. Echocardiography has been increasingly employed as a nonclinical assessment tool for measuring left ventricular systolic function, heart chamber size, and indices of hypertrophy, which have clinical relevance. Standard telemetric cardiovascular endpoints cannot always provide insight into changes in these clinically meaningful endpoints. No clear guidelines for...
Enhanced Pre- and Post-Natal Development Studies in the Nonhuman Primate Model: Experiences with Social Housing
Teratology 2016 -- Regulatory guidance for preclinical safety assessment of biopharmaceuticals (e.g. monoclonal antibodies) by ICH M3(R2) and ICH S6(R1) is associated with frequent demand for nonhuman primate models as the relevant species for developmental toxicity testing. Typically, an enhanced pre- and post-natal development (ePPND) study is conducted. Although studies involving pregnant animals are still considered a special challenge, moving towards social housing has had a positive...
Effects of Social Housing on Cannibalism in Mice and Rats
ACT 2016 -- With the increasing focus on animal welfare and 3Rs, there has been a move toward socially housing animals. The Guide for the Care and Use of Laboratory Animals states that "single housing of social species should be the exception and justified based on experimental requirements or veterinary-related concerns about animal well-being. In these cases, it should be limited to the minimum period necessary…" However, initially there were concerns that social housing would result in...