Drug Safety Evaluation

This second edition provides up-to-date chapters and new chapters focusing on the most recent advances in the field of drug safety evaluation. Divided into seven parts, chapters detail specific aspects related to the experimental design of preclinical studies conducted to support the safety of pediatric and combination drugs, necropsy and histopathology evaluation, mass spectrometry imaging, genetic toxicology protocols including the Pig-a mutation assay, safety pharmacology methods such as automatization of patch-clamp procedures, target safety assessment for investigative toxicology, screening assays for developmental toxicology, and methods to characterize novel translational safety biomarkers like microRNAs. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting to avoid known pitfalls.

Authoritative and practical, Drug Safety Evaluation: Methods and Protocols, Second Edition aims to ensure successful results in the further study of this vital field.

Includes cutting-edge methods and protocols Provides step-by-step detail essential for reproducible results Contains key notes and implementation advice from the experts

Inhalt
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.*