Drug Safety Evaluation: Methods and Protocols [Hardcover]

Non-clinical drug safety evaluation, the assessment of the safety profile of therapeutic agents through the conduct of laboratory studies in in vitro systems and in animals, is an essential step in the progress of new pharmaceuticals heading toward the ultimate goal of clinical trials and, eventually, approval. In Drug Safety Evaluation: Methods and Protocols, expert researchers detail a compendium of analytical technologies with a focus on clarity and applicability in real life laboratory practice. These meticulous contributions feature key topics such as acute to chronic general toxicity studies, histopathology studies, reproductive toxicity studies, genotoxicity studies, safety pharmacology studies, investigative toxicity studies, and safety biomarker studies. As a volume in the highly successful Methods in Molecular Biology series, chapters include brief introductions to their respective subjects, lists of the necessary materials, step-by-step, readily reproducible protocols, and tips on troubleshooting and avoiding known pitfalls.Comprehensive and authoritative, Drug Safety Evaluation: Methods and Protocols serves as an ideal guide to this field, helpful to pharmaceutical scientists, toxicologists, biochemists, and molecular biologists as well as scientists from all other disciplines who wish to translate these thorough methods into their own work.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 EleclÓC