Drug Safety Evaluation : Methods and Protocols.

✍ Scribed by Gautier, Jean-Charles (Ed.)

• Publisher: Humana Press
• Year: 2017
• Tongue: English
• Leaves: 425
• Series: Methods in Molecular Biology
• Edition: 2
• Category: Library

✦ Synopsis

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.

✦ Table of Contents

Part I: General Toxicology 1. Nonclinical Development of Combination Drugs Alberto Lodola2. Juvenile Non-Clinical Safety Studies in Support of Pediatric Drug DevelopmentPaul C. Barrow and Georg Schmitt Part II:Pathology3. Procedures of Necropsy and Tissue SamplingLaurence Fiette, Mohamed Slaoui, and Anne-Laure Bauchet 4. Tissue Sampling and Processing for Histopathology EvaluationMohamed Slaoui, Anne-Laure Bauchet, and Laurence Fiette 5. Principles and Methods of ImmunohistochemistryJose A. Ramos-Vara 6. Applications of Mass Spectrometry Imaging for Safety EvaluationDavid Bonnel and Jonathan Stauber Part III Genetic Toxicology 7. 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 geneVasily N Dobrovolsky, Javier Revollo, Dayton M Petibone, and Robert H Heflich 8. Detection of In Vivo Mutation in the Pig-a Gene of Mouse Bone Marrow ErythroidsTakafumi Kimoto and Daishiro Miura&lt
9. The Use of Bacterial Repair Endonucleases in the Comet Assay Andrew R. Collins Part IV Safety Pharmacology 10. Automated Patch-Clamp methods for the hERG Cardiac Potassium Channel Sylvie Houtmann, Brigitte Schombert, Camille Sanson, Michel Partiseti, and G. Andrees Bohme 11. Impedance Measurement in Induced Pluripotent Stem Cell Derived CardiomyocytesEmma-Jane Poulton Part V Investigative Toxicology12. Target Safety Assessment: Strategies and Resources Richard J. Brennan 13. NMR and MS Methods for Metabolomics Alexander Amberg, Bjorn Riefke, Gotz Schlotterbeck, Alfred Ross, Hans Senn, Frank Dieterle, and Matthias Keck 14. Protocols and Applications of Cellular Metabolomics in Safety Studies Using Precision-Cut Tissue Slices and Carbon 13 NMR Gabriel Baverel, Maha El Hage, and Guy Martin 15. Statistical Analysis of Quantitative RT-PCR Results Richard Khan-Malek and Ying Wang 16. Evaluation of Mitochondrial Respiration in Cultured Rat Hepatocytes Jean-Pierre Marchandeau and Gilles Labbe Part VI Screening Assays for Developmental Toxicity 17. FETAX Assay for Evaluation of Developmental Toxicity Isabelle Mouche, Laure Malesic, and Olivier Gillardeaux 18. Evaluation of Embryotoxicity Using the Zebrafish Model&lt
Lisa Truong and Robert L. Tanguay Part VII Safety Biomarkers19. Absolute Quantification of Toxicological Biomarkers via Mass Spectrometry Thomas Y. K. Lau, Ben C. Collins, Peter Stone, Ning Tang, William M. Gallagher, and Stephen R. Pennington 20. Next-Generation Sequencing to investigate urinary microRNAs from Macaca fascicularis (Cynomolgus Monkey) Yaligara Veeranagouda, Jean-Francois Leonard, Jean-Charles Gautier, and Eric Boitier 21. Quantitative RT-PCR for MicroRNAs in Biofluids Michael Thorsen, Thorarinn Blondal, and Peter Mouritzen 22. Chromogenic In Situ Hybridization Methods for microRNA Biomarker Monitoring of Drug Safety and EfficacyBarbara Gould, Tina Damgaard, and Boye Schnack Nielsen 23. Urine Exosome Isolation and CharacterizationJonathan M. Street, Erik H. Koritzinsky, Deonna M. Glispie, and Peter S.T. Yuen