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Main description:
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 (TM) 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.
Contents:
Part I: General Toxicology
1. Developing Combination Drugs in Preclinical Studies
Alberto Lodola
2. Preclinical Evaluation of Juvenile Toxicity
Paul C. Barrow, Stephane Barbellion, and Jeanne Stadler
Part II: Pathology
3. Necropsy and Sampling Procedures in Rodents
Laurence Fiette and Mohamed Slaoui
4. Histopathology Procedures: From Tissue Sampling to Histopathological Evaluation
Mohamed Slaoui and Laurence Fiette
5. Principles and Methods of Immunohistochemistry
Jose A. Ramos-Vara
6. Tissue Microarrays and Digital Image Analysis
Denise Ryan, Laoighse Mulrane, Elton Rexhepaj, and William M. Gallagher
Part III: Genetic Toxicology
7. Micronucleus Assay and Labeling of Centromeres with FISH Technique
Ilse Decordier, Raluca Mateuca, and Micheline Kirsch-Volders
8. The Use of Bacterial Repair Endonucleases in the Comet Assay
Andrew R. Collins
Part IV: Safety Pharmacology
9. Manual Whole-Cell Patch-Clamping of the HERG Cardiac K+ Channel
Xiao-Liang Chen, Jiesheng Kang, and David Rampe
Part V: Generation and Analysis of Transcriptomics Data
10. Generation and Analysis of Transcriptomics Data
Philip D. Glaves and Jonathan D. Tugwood
11. Protocols of Two-Dimensional Difference Gel Electrophoresis (2D-DIGE) to Investigate Mechanisms of Toxicity
Emmanuelle Com, Albrecht Gruhler, Martine Courcol, and Jean-Charles Gautier
12. 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, Agnes Duplany, Bernard Ferrier, and Guy Martin
13. Statistical Analysis of Quantitative RT-PCR Results
Richard Khan-Malek and Ying Wang
14. Evaluation of Mitochondrial Respiration in Cultured Rat Hepatocytes
Jean-Pierre Marchandeau and Gilles Labbe
Part VI : Screening Assays for Developmental Toxicity
15. FETAX Assay for Evaluation of Developmental Toxicity
Isabelle Mouche, Laure Malesic, and Olivier Gillardeaux
16. Evaluation of Embryotoxicity Using the Zebrafish Model
Lisa Truong, Stacey L. Harper, and Robert L. Tanguay
Part VII: Chemical Protein Adducts
17. Protocols of In vitro Protein Covalent Binding Studies in Liver
Jean-Francois Levesque, Stephen H. Day, and Allen N. Jones
18. 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
19. 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
20. 1-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
21. 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
22. Optimization of SELDI for Biomarker Detection in Plasma
Jean-Francois Leonard, Martine Courcol, and Jean-Charles Gautier
23. Differential Proteomics Incorporating iTRAQ Labelling and Multi-Dimensional Separations
Ben C. Collins, Thomas Y.K. Lau, Stephen R. Pennington, and William M. Gallagher
24. NMR and MS Methods for Metabonomics
Frank Dieterle, Bjoern Riefke, Goetz Schlotterbeck, Alfred Ross, Hans Senn, and Alexander Amberg
25. 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
PRODUCT DETAILS
Publisher: Springer (Humana Press Inc.)
Publication date: October, 2010
Pages: 444
Weight: 1027g
Availability: Available
Subcategories: General Issues, Pharmacology
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