Drug Safety Evaluation

From the reviews:“Describes in detail the standard, analytical methodologies that are used to evaluate the safety of a new compound or a particular compound’s use in a vulnerable patient population. … This is intended to serve as a resource for a variety of basic science researchers, as well as anyone interested in the methods used in evaluating drug safety in a preclinical setting. … This a very technical overview of the standard laboratory procedures and protocols used in the preclinical evaluation of drug safety.” (Rachel R. Chennault, Doody’s Review Service, April, 2011)

• Developing Combination Drugs in Preclinical Studies.- Preclinical Evaluation of Juvenile Toxicity.- Necropsy and Sampling Procedures in Rodents.- Histopathology Procedures: From Tissue Sampling to Histopathological Evaluation.- Principles and Methods of Immunohistochemistry.- Tissue Microarrays and Digital Image Analysis.- Micronucleus Assay and Labeling of Centromeres with FISH Technique.- The Use of Bacterial Repair Endonucleases in the Comet Assay.- Manual Whole-Cell Patch-Clamping of the HERG Cardiac K+ Channel.- Generation and Analysis of Transcriptomics Data.- Protocols of Two-Dimensional Difference Gel Electrophoresis (2D-DIGE) to Investigate Mechanisms of Toxicity.- 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.- Protocols of In vitro Protein Covalent Binding Studies in Liver.- Utilization of MALDI-TOF to Determine Chemical-Protein Adduct Formation In vitro.- Utilization of LC-MS/MS Analyses to Identify Site-Specific Chemical Protein Adducts In vitro.- 1-Dimensional Western Blotting Coupled to LC-MS/MS Analysis to Identify Chemical-Adducted Proteins in Rat Urine.- Identification of Chemical Adducted Proteins in Urine by Multi-Dimensional Protein Identification Technology (LC/LC-MS/MS).- Optimization of SELDI for Biomarker Detection in Plasma.- Differential Proteomics Incorporating iTRAQ Labelling and Multi-Dimensional Separations.- NMR and MS Methods for Metabonomics.- Absolute Quantification of Toxicological Biomarkers by Multiple Reaction Monitoring.