| Description |
1 online resource (xi, 427 pages) : illustrations (some color) |
| Series |
Methods in molecular biology, 1940-6029 ; volume no. 1641 |
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Methods in molecular biology (Clifton, N.J.) ; v. 1641. 1064-3745
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| Contents |
Nonclinical development of combination drugs / Alberto Lodola -- Juvenile nonclinical safety studies in support of pediatric drug development / Paul C. Barrow and Georg Schmitt -- Procedures of necropsy and tissue sampling / Laurence Fiette, Mohamed Slaoui, and Anne-Laure Bauchet -- Tissue sampling and processing for histopathology evaluation / Mohamed Slaoui, Anne-Laure Bauchet, and Laurence Fiette -- Principles and methods of immunohistochemistry / José A. Ramos-Vara -- Applications of mass spectrometry imaging for safety evaluation / David Bonnel and Jonathan Stauber Part III Genetic Toxicology -- 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 / Vasily N. Dobrovolsky, Javier Revollo, Dayton M. Petibone, and Robert H. Heflich -- Detection of in vivo mutation in the Pig-a gene of mouse bone marrow erythroids / Takafumi Kimoto and Daishiro Miura -- Use of bacterial repair endonucleases in the comet assay / Andrew R. Collins -- Automated patch-clamp methods for the hERG cardiac potassium channel / Sylvie Houtmann, Brigitte Schombert, Camille Sanson, Michel Partiseti, and G. Andrees Bohme -- Impedance measurement in induced pluripotent stem cell-derived cardiomyocytes / Emma-Jane Poulton -- Target safety assessment : strategies and resources / Richard J. Brennan -- NMR and MS methods for metabolomics / Alexander Amberg, Björn Riefke, Götz Schlotterbeck, Alfred Ross, Hans Senn, Frank Dieterle, and Matthias Keck -- 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 -- Statistical analysis of auantitative RT-PCR results / Richard Khan-Malek and Ying Wang -- Evaluation of mitochondrial respiration in cultured rat hepatocytes / Jean-Pierre Marchandeau and Gilles Labbe -- FETAX assay for evaluation of developmental toxicity / Isabelle Mouche, Laure Malésic, and Olivier Gillardeaux -- Evaluation of embryotoxicity using the Zebrafish model / Lisa Truong and Robert L. Tanguay -- 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 -- Next-generation sequencing to investigate urinary microRNAs from Macaca fascicularis (cynomolgus monkey) / Yaligara Veeranagouda, Jean-François Léonard, Jean-Charles Gautier, and Eric Boitier -- Quantitative RT-PCR for microRNAs in biofluids / Michael Thorsen, Thorarinn Blondal, and Peter Mouritzen -- Chromogenic in situ hybridization methods for microRNA biomarker monitoring of drug safety and efficacy / Barbara R. Gould, Tina Damgaard, and Boye Schnack Nielsen -- Urine exosome isolation and characterization / Jonathan M. Street, Erik H. Koritzinsky, Deonna M. Glispie, and Peter S.T. Yuen |
| Summary |
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 |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Online resource; title from PDF title page (SpringerLink, viewed July 31, 2017) |
| Subject |
Drugs -- Toxicology.
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Drugs -- Testing.
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Poisoning.
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Drugs -- Side effects.
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Evaluation Studies as Topic
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Poisoning
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Investigative Techniques
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Drug Discovery -- methods
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Substance-Related Disorders
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Drug Evaluation, Preclinical -- methods
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Drug-Related Side Effects and Adverse Reactions
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Toxicity Tests
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Pharmacology.
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Medical -- Pharmacology.
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Drugs -- Testing
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Drugs -- Toxicology
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| Genre/Form |
Laboratory manuals
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Laboratory manuals.
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| Form |
Electronic book
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| Author |
Gautier, Jean-Charles, editor
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| ISBN |
9781493971725 |
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1493971727 |
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