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" Drug safety evaluation : "
edited by Jean-Charles Gautier.
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BL
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| Record Number
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988094
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b742464
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| Title & Author
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Drug safety evaluation : : methods and protocols /\ edited by Jean-Charles Gautier.
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| Publication Statement
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New York :: Humana Press,, ©2011.
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| Series Statement
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Methods in molecular biology ;; v. 691
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| Page. NO
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1 online resource (xiii, 431 pages) :: illustrations
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| ISBN
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1607618494
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: 9781607618492
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1603271864
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9781603271868
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| Bibliographies/Indexes
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Includes bibliographical references and index.
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| Contents
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Part I General Toxicology -- Developing Combination Drugs in Preclinical Studies / Alberto Lodola -- Preclinical Evaluation of Juvenile Toxicity / Paul C. Barrow, Stéphane Barbellion, and Jeanne Stadler -- Part II Pathology -- Necropsy and Sampling Procedures in Rodents / Laurence Fiette and Mohamed Slaoui -- Histopathology Procedures: From Tissue Sampling to Histopathological Evaluation / Mohamed Slaoui and Laurence Fiette -- Principles and Methods of Immunohistochemistry / José A. Ramos-Vara -- Tissue Microarrays and Digital Image Analysis / Denise Ryan, Laoighse Mulrane, Elton Rexhepaj, and William M. Gallagher -- Part III Genetic Toxicology -- Micronucleus Assay and Labeling of Centromeres with FISH Technique / Ilse Decordier, Raluca Mateuca, and Micheline Kirsch-Volders -- The Use of Bacterial Repair Endonucleases in the Comet Assay / Andrew R. Collins -- Part IV Safety Pharmacology -- Manual Whole-Cell Patch-Clamping of the HERG Cardiac K+ Channel / Xiao-Liang Chen, Jiesheng Kang, and David Rampe -- Part V Investig ativ e Toxicology -- Generation and Analysis of Transcriptomics Data / Philip D. Glaves and Jonathan D. Tugwood -- Protocols of Two-Dimensional Difference Gel Electrophoresis to Investigate Mechanisms of Toxicity / Emmanuelle Com, Albrecht Gruhler, Martine Courcol, and Jean-Charles Gautier -- Protocols and Applications of Cellular Metabolomics in Safety Studies Using Precision-Cut Tissue Slices and Carbon 13 NMR / Gabriel Baverel, Sophie Renault, Hassan Faiz, Maha El Hage, Catherine Gauthier, Agnès Duplany, Bernard Ferrier, and Guy Martin -- Statistical Analysis of Quantitative RT-PCR Results / Richard Khan-Malek and Ying Wang -- Evaluation of Mitochondrial Respiration in Cultured Rat Hepatocytes / Jean-Pierre Marchandeau and Gilles Labbe -- Part VI Screening Ass ays for Developmental Toxicity -- FETAX Assay for Evaluation of Developmental Toxicity / Isabelle Mouche, Laure Malesic, and Olivier Gillardeaux -- Evaluation of Embryotoxicity Using the Zebrafish Model / Lisa Truong, Stacey L. Harper, and Robert L. Tanguay -- Part VII Chemical Protein Adducts -- Protocols of In Vitro Protein Covalent Binding Studies in Liver / Jean-François Lévesque, Stephen H. Day, and Allen N. Jones -- Utilization of MALDI-TOF to Determine Chemical-Protein Adduct Formation In Vitro / Ashley A. Fisher, Matthew T. Labenski, Terrence J. Monks, and Serrine S. Lau -- Utilization of LC-MS/MS Analyses to Identify Site-Specific Chemical Protein Adducts In Vitro / Ashley A. Fisher, Matthew T. Labenski, Terrence J. Monks, and Serrine S. Lau -- One-Dimensional Western Blotting Coupled to LC-MS/MS Analysis to Identify Chemical-Adducted Proteins in Rat Urine / Matthew T. Labenski, Ashley A. Fisher, Terrence J. Monks, and Serrine S. Lau -- Identification of Chemical-Adducted Proteins in Urine by Multi-dimensional Protein Identification Technology (LC/LC-MS/MS) / Matthew T. Labenski, Ashley A. Fisher, Terrence J. Monks, and Serrine S. Lau -- Part VIII Safety Biomarkers -- Optimization of SELDI for Biomarker Detection in Plasma / Jean-Francois Léonard, Martine Courcol, and Jean-Charles Gautier -- Differential Proteomics Incorporating iTRAQ Labeling and Multi-dimensional Separations / Ben C. Collins, Thomas Y.K. Lau, Stephen R. Pennington, and William M. Gallagher -- NMR and MS Methods for Metabonomics / Frank Dieterle, Björn Riefke, Gotz Schlotterbeck, Alfred Ross, Hans Senn, and Alexander Amberg -- Absolute Quantification of Toxicological Biomarkers by Multiple Reaction Monitoring / Thomas Y.K. Lau, Ben C. Collins, Peter Stone, Ning Tang, William M. Gallagher, and Stephen R. Pennington.
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| Abstract
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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.
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Drugs-- Testing.
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Analytical, Diagnostic and Therapeutic Techniques and Equipment
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Disease.
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Drug Discovery.
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Drug Evaluation, Preclinical.
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Drug-Related Side Effects and Adverse Reactions.
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Evaluation Studies as Topic.
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Investigative Techniques
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Methods.
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Poisoning.
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Substance-Related Disorders.
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Toxicity Tests.
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Drugs-- Testing.
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| Dewey Classification
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615/.19
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| LC Classification
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RM301.25.D78 2011
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| NLM classification
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QV771
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| Added Entry
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Gautier, Jean-Charles.
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