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Showing results 353 - 368 of 91813 for .

Showing results 353 - 368 of 91813 for .

Method Enhancement for Intrathecal Lumbar Bolus Delivery and CSF Sampling in the Anesthetized Cynomolgus Monkey for the Safety Assessment of Oligonucleotides
ACT 2015 - Oligonucleotide-based therapeutics have a long investigational history for the treatment of human diseases. However, only in the last decade their promise as a new drug modality has being realized, especially deployed in the discovery of RNA interference (RNAi) and an endogenous mechanism to regulate target mRNA. Overall, crossing the blood-brain barrier becomes an increasing need in terms of drug delivery for pharmaceutical effectiveness.
Standardized Neurological and Physical Diagnostics during Intrathecal Drug Delivery of Cynomolgus Monkeys: You'd Better Know the Background Findings
ACT 2015 - Detailed neurological and physical examinations are an essential part of toxicity studies in cynomolgus monkeys undergoing intrathecal drug delivery. The scientific literature, however, reveals little background data of such parameters. The current work shall overcome this gap and also help to reduce the number of control animals in future studies (currently required for comparison reasons) in terms of the 3R's (reduction, refinement and replacement).
Enhanced Imaging Has Proven to Be a Safety Net During the Conduct of Regulatory Studies with Nonhuman Primates: The Value of Hard Data Before Necropsy
ACT 2016 -- The cynomolgus monkey (Macaca fascicularis) represents an important nonhuman primate model for preclinical safety evaluation, because it has repeatedly shown to predict toxicity and pharmacodynamics of many pharmaceuticals under development. The present work examined the use of multi-slice spiral computed tomography (CT) and magnetic resonance imaging (MRI) for additional in vivo imaging during the conduct of regulated nonhuman primate toxicity studies. CT produces detailed...
Echocardiography Group Size Requirements in Canine Toxicology Studies Based on Power Analysis
SPS 2016 -- Echocardiography is used in nonclinical studies as a non-invasive technique to evaluate heart size and function. One frequent question is how sensitive echocardiography is to detect quantitative changes. This study used power analysis to determine the necessary group size needed in a canine toxicology study to detect differences within echocardiography parameters.