Drug Safety Evaluation

Nonclinical Development of Combination Drugs.- Juvenile Non-Clinical Safety Studies in Support of Pediatric Drug Development.- Procedures of Necropsy and Tissue Sampling.- Tissue Sampling and Processing for Histopathology Evaluation.- Principles and Methods of Immunohistochemistry.- Applications of Mass Spectrometry Imaging for Safety Evaluation.- In vivo rat T-lymphocyte Pig-a assay: detection and expansion of cells deficient in the GPI-anchored CD48 surface marker for analysis of mutation in the endogenous Pig-a gene.- Detection of In Vivo Mutation in the Pig-a Gene of Mouse Bone Marrow Erythroids.- The Use of Bacterial Repair Endonucleases in the Comet Assay.- Automated Patch-Clamp methods for the hERG Cardiac Potassium Channel.- Impedance Measurement in Induced Pluripotent Stem Cell Derived  Cardiomyocytes.- Target Safety Assessment: Strategies and Resources.- NMR and MS Methods for Metabolomics.- Protocols and Applications of Cellular Metabolomics in Safety Studies Using Precision-Cut Tissue Slices and Carbon 13 NMR.- Statistical Analysis of Quantitative RT-PCR Results.- Evaluation of Mitochondrial Respiration in Cultured Rat Hepatocytes.- FETAX Assay for Evaluation of Developmental Toxicity.- Evaluation of Embryotoxicity Using the Zebrafish Model.- Absolute Quantification of Toxicological Biomarkers via Mass Spectrometry.- Next-Generation Sequencing to investigate urinary microRNAs from Macaca fascicularis (Cynomolgus Monkey).- Quantitative RT-PCR for MicroRNAs in Biofluids.- Chromogenic In Situ Hybridization Methods for microRNA Biomarker Monitoring of Drug Safety and Efficacy.- Urine Exosome Isolation and Characterization.