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E-book: Drug Safety Evaluation: Methods and Protocols

  • Format: EPUB+DRM
  • Series: Methods in Molecular Biology 1641
  • Pub. Date: 25-Jul-2017
  • Publisher: Humana Press Inc.
  • Language: eng
  • ISBN-13: 9781493971725
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  • Format: EPUB+DRM
  • Series: Methods in Molecular Biology 1641
  • Pub. Date: 25-Jul-2017
  • Publisher: Humana Press Inc.
  • Language: eng
  • ISBN-13: 9781493971725
Other books in subject:

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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.

Preface v
Contributors ix
Part I General Toxicology
1 Nonclinical Development of Combination Drugs
3(22)
Alberto Lodola
2 Juvenile Nonclinical Safety Studies in Support of Pediatric Drug Development
25(46)
Paul C. Barrow
Georg Schmitt
Part II Pathology
3 Procedures of Necropsy and Tissue Sampling
71(30)
Laurence Fiette
Mohamed Slaoui
Anne-Laure Bauchet
4 Tissue Sampling and Processing for Histopathology Evaluation
101(14)
Mohamed Slaoui
Anne-Laure Bauchet
Laurence Fiette
5 Principles and Methods of Immunohistochemistry
115(14)
Jose A. Ramos-Vara
6 Applications of Mass Spectrometry Imaging for Safety Evaluation
129(14)
David Bonnel
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 Gene
143(18)
Vastly N. Dobrovolsky
Javier Revollo
Dayton M. Petibone
Robert H. Heflich
8 Detection of In Vivo Mutation in the Pig-a Gene of Mouse Bone Marrow Erythroids
161(12)
Takafumi Kimoto
Daishiro Miura
9 The Use of Bacterial Repair Endonucleases in the Comet Assay
173(14)
Andrew R. Collins
Part IV Safety Pharmacology
10 Automated Patch-Clamp Methods for the hERG Cardiac Potassium Channel
187(14)
Sylvie Houtmann
Brigitte Schombert
Camille Sanson
Michel Partiseti
G. Andrees Bohme
11 Impedance Measurement in Induced Pluripotent Stem Cell-Derived Cardiomyocytes
201(12)
Emma-Jane Poulton
Part V Investigative Toxicology
12 Target Safety Assessment: Strategies and Resources
213(16)
Richard J. Brennan
13 NMR and MS Methods for Metabolomics
229(30)
Alexander Amberg
Bjorn Riefke
Gotz Schlotterbeck
Alfred Ross
Hans Senn
Frank Dieterle
Matthias Keck
14 Protocols and Applications of Cellular Metabolomics in Safety Studies Using Precision-Cut Tissue Slices and Carbon 13 NMR
259(22)
Gabriel Baverel
Maha El Hage
Guy Martin
15 Statistical Analysis of Quantitative RT-PCR Results
281(16)
Richard Khan-Malek
Ying Wang
16 Evaluation of Mitochondrial Respiration in Cultured Rat Hepatocytes
297(14)
Jean-Pierre Marchandeau
Gilles Labbe
Part VI Screening Assays for Developmental Toxicity
17 FETAX Assay for Evaluation of Developmental Toxicity
311(14)
Isabelle Mouche
Laure Malesic
Olivier Gillardeaux
18 Evaluation of Embryo toxicity Using the Zebrafish Model
325(12)
Lisa Truong
Robert L. Tanguay
Part VII Safety Biomarkers
19 Absolute Quantification of Toxicological Biomarkers via Mass Spectrometry
337(12)
Thomas Y. K. Lau
Ben C. Collins
Peter Stone
Ning Tang
William M. Gallagher
Stephen R. Pennington
20 Next-Generation Sequencing to Investigate Urinary microRNAs from Macaca fascicularis (Cynomolgus Monkey)
349(30)
Yaligara Veeranagouda
Jean-Francois Leonard
Jean-Charles Gautier
Eric Boitier
21 Quantitative RT-PCR for MicroRNAs in Biofluids
379(20)
Michael Thorsen
Thorarinn Blondal
Peter Mouritzen
22 Chromogenic In Situ Hybridization Methods for microRNA Biomarker Monitoring of Drug Safety and Efficacy
399(14)
Barbara R. Gould
Tina Damgaard
Boye Schnack Nielsen
23 Urine Exosome Isolation and Characterization
413(12)
Jonathan M. Street
Erik H. Koritzinsky
Deonna M. Glispie
Peter S.T. Yuen
Index 425