Drug Safety Evaluation Methods and Protocols

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, eventuall...

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Bibliographic Details
Other Authors: Gautier, Jean-Charles (Editor)
Format: eBook
Language:English
Published: Totowa, NJ Humana Press 2011, 2011
Edition:1st ed. 2011
Series:Methods in Molecular Biology
Subjects:
Online Access:
Collection: Springer eBooks 2005- - Collection details see MPG.ReNa
Table of Contents:
  • Developing Combination Drugs in Preclinical Studies
  • Preclinical Evaluation of Juvenile Toxicity
  • Necropsy and Sampling Procedures in Rodents
  • Histopathology Procedures: From Tissue Sampling to Histopathological Evaluation
  • Principles and Methods of Immunohistochemistry
  • Tissue Microarrays and Digital Image Analysis
  • Micronucleus Assay and Labeling of Centromeres with FISH Technique
  • The Use of Bacterial Repair Endonucleases in the Comet Assay
  • Manual Whole-Cell Patch-Clamping of the HERG Cardiac K+ Channel
  • Generation and Analysis of Transcriptomics Data
  • Protocols of Two-Dimensional Difference Gel Electrophoresis (2D-DIGE) to Investigate Mechanisms of Toxicity
  • Protocols and Applications of Cellular Metabolomics in Safety Studies Using Precision-Cut Tissue Slices and Carbon 13 NMR
  • Statistical Analysis of Quantitative RT-PCR Results
  • Evaluation of Mitochondrial Respiration in Cultured Rat Hepatocytes
  • FETAX Assay for Evaluation of Developmental Toxicity
  • Evaluation of Embryotoxicity Using the Zebrafish Model
  • Protocols of In vitro Protein Covalent Binding Studies in Liver
  • Utilization of MALDI-TOF to Determine Chemical-Protein Adduct Formation In vitro
  • Utilization of LC-MS/MS Analyses to Identify Site-Specific Chemical Protein Adducts In vitro
  • 1-Dimensional Western Blotting Coupled to LC-MS/MS Analysis to Identify Chemical-Adducted Proteins in Rat Urine
  • Identification of Chemical Adducted Proteins in Urine by Multi-Dimensional Protein Identification Technology (LC/LC-MS/MS)
  • Optimization of SELDI for Biomarker Detection in Plasma
  • Differential Proteomics Incorporating iTRAQ Labelling and Multi-Dimensional Separations
  • NMR and MS Methods for Metabonomics
  • Absolute Quantification of Toxicological Biomarkers by Multiple Reaction Monitoring