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Titlebook: Drug Safety Evaluation; Methods and Protocol Jean-Charles Gautier Book 2017Latest edition Springer Science+Business Media LLC 2017 immunohi

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Target Safety Assessment: Strategies and Resourcessful application in early discovery programs. This chapter presents a summary of some of the information types and sources that should be investigated, and approaches that can be taken to generate an early assessment of potential safety liabilities.
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Juvenile Nonclinical Safety Studies in Support of Pediatric Drug Developmentranted previously. Nonclinical juvenile toxicity studies are often required as part of this assessment. The protocols for juvenile toxicity studies are best devised in consultation with the regulatory authorities. It is important to submit the pediatric investigation plan (PIP) or pediatric study pl
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Procedures of Necropsy and Tissue Sampling critical tissue samples may be stored for the subsequent evaluation. It is therefore important that the personnel in charge of this key experimental step to be adequately trained and aware of the study endpoints.
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Tissue Sampling and Processing for Histopathology Evaluationidentify either spontaneous or diseases-induced changes. Routinely, tissues are fixed with neutral formalin 10%, embedded in paraffin, and manually sectioned with a microtome to obtain 4–5 μm thick paraffin sections. Dewaxed sections are then stained with HE&S (hematoxylin-eosin and saffron) or can
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Applications of Mass Spectrometry Imaging for Safety Evaluation in biology. Developed over 50 years ago, and with different principles to detect and map compounds on a sample surface, MSI supports modern biology questions by detecting biological compounds within tissue sections. MALDI (matrix-assisted laser desorption/ionization) imaging trend analysis in this
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