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E-grāmata: Drug Safety Evaluation: Methods and Protocols

  • Formāts: EPUB+DRM
  • Sērija : Methods in Molecular Biology 691
  • Izdošanas datums: 23-Oct-2010
  • Izdevniecība: Humana Press Inc.
  • Valoda: eng
  • ISBN-13: 9781607618492
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  • Formāts: EPUB+DRM
  • Sērija : Methods in Molecular Biology 691
  • Izdošanas datums: 23-Oct-2010
  • Izdevniecība: Humana Press Inc.
  • Valoda: eng
  • ISBN-13: 9781607618492
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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.

Recenzijas

From the reviews:

Describes in detail the standard, analytical methodologies that are used to evaluate the safety of a new compound or a particular compounds use in a vulnerable patient population. This is intended to serve as a resource for a variety of basic science researchers, as well as anyone interested in the methods used in evaluating drug safety in a preclinical setting. This a very technical overview of the standard laboratory procedures and protocols used in the preclinical evaluation of drug safety. (Rachel R. Chennault, Doodys Review Service, April, 2011)

Preface v
Contributors xi
PART I GENERAL TOXICOLOGY
1 Developing Combination Drugs in Preclinical Studies
3(14)
Alberto Lodola
2 Preclinical Evaluation of Juvenile Toxicity
17(22)
Paul C. Barrow
Stephane Barbellion
Jeanne Stadler
PART II PATHOLOGY
3 Necropsy and Sampling Procedures in Rodents
39(30)
Laurence Fiette
Mohamed Slaoui
4 Histopathology Procedures: From Tissue Sampling to Histopathological Evaluation
69(14)
Mohamed Slaoui
Laurence Fiette
5 Principles and Methods of Immunohistochemistry
83(14)
Jose A. Ramos-Vara
6 Tissue Microarrays and Digital Image Analysis
97(18)
Denise Ryan
Laoighse Mulrane
Elton Rexhepaj
William M. Gallagher
PART III GENETIC TOXICOLOGY
7 Micronucleus Assay and Labeling of Centromeres with FISH Technique
115(22)
Ilse Decordier
Raluca Mateuca
Micheline Kirsch-Volders
8 The Use of Bacterial Repair Endonucleases in the Comet Assay
137(14)
Andrew R. Collins
PART IV SAFETY PHARMACOLOGY
9 Manual Whole-Cell Patch-Clamping of the HERG Cardiac K+ Channel
151(16)
Xiao-Liang Chen
Jiesheng Kang
David Rampe
PART V INVESTIGATIVE TOXICOLOGY
10 Generation and Analysis of Transcriptomics Data
167(20)
Philip D. Glaves
Jonathan D. Tugwood
11 Protocols of Two-Dimensional Difference Gel Electrophoresis to Investigate Mechanisms of Toxicity
187(18)
Emmanuelle Com
Albrecht Gruhler
Martine Courcol
Jean-Charles Gautier
12 Protocols and Applications of Cellular Metabolomics in Safety Studies Using Precision-Cut Tissue Slices and Carbon 13 NMR
205(22)
Gabriel Baverel
Sophie Renault
Hassan Faiz
Maha El Hage
Catherine Gauthier
Agnes Duplany
Bernard Ferrier
Guy Martin
13 Statistical Analysis of Quantitative RT-PCR Results
227(16)
Richard Khan-Malek
Ting Wang
14 Evaluation of Mitochondrial Respiration in Cultured Rat Hepatocytes
243(14)
Jean-Pierre Marchandeau
Gilles Labbe
PART VI SCREENING ASSAYS FOR DEVELOPMENTAL TOXICITY
15 FETAX Assay for Evaluation of Developmental Toxicity
257(14)
Isabelle Mouche
Laure Malesic
Olivier Gillardeaux
16 Evaluation of Embryotoxicity Using the Zebrafish Model
271(12)
Lisa Truong
Stacey L. Harper
Robert L. Tanguay
PART VII CHEMICAL PROTEIN ADDUCTS
17 Protocols of In Vitro Protein Covalent Binding Studies in Liver
283(20)
Jean-Francois Levesque
Stephen H. Day
Allen N. Jones
18 Utilization of MALDI-TOF to Determine Chemical-Protein Adduct Formation In Vitro
303(14)
Ashley A. Fisher
Matthew T. Labenski
Terrence J. Monks
Serrine S. Lau
19 Utilization of LC-MS/MS Analyses to Identify Site-Specific Chemical Protein Adducts In Vitro
317(10)
Ashley A. Fisher
Matthew T. Labenski
Terrence J. Monks
Serrine S. Lau
20 One-Dimensional Western Blotting Coupled to LC-MS/MS Analysis to Identify Chemical-Adducted Proteins in Rat Urine
327(12)
Matthew T. Labenski
Ashley A. Fisher
Terrence J. Monks
Serrine S. Lau
21 Identification of Chemical-Adducted Proteins in Urine by Multi-dimensional Protein Identification Technology (LC/LC-MS/MS)
339(12)
Matthew T. Labenski
Ashley A. Fisher
Terrence J. Monks
Serrine S. Lau
PART VIII SAFETY BIOMARKERS
22 Optimization of SELDI for Biomarker Detection in Plasma
351(18)
Jean-Francois Leonard
Martine Courcol
Jean-Charles Gautier
23 Differential Proteomics Incorporating iTRAQ Labeling and Multi-dimensional Separations
369(16)
Ben C. Collins
Thomas Y.K. Lau
Stephen R. Pennington
William M. Gallagher
24 NMR and MS Methods for Metabonomics
385(32)
Frank Dieterle
Bjorn Riefke
Gotz Schotterbeck
Alfred Ross
Hans Senn
Alexander Amberg
25 Absolute Quantification of Toxicological Biomarkers by Multiple Reaction Monitoring
417(12)
Thomas Y. K. Lau
Ben C. Collins
Peter Stone
Ning Tang
William M. Gallagher
Stephen R. Pennington
Index 429