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Drug Safety Evaluation

  • Kartonierter Einband
  • 448 Seiten
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Non-clinical drug safety evaluation, the assessment of the safety profile of therapeutic agents through the conduct of laboratory ... Weiterlesen
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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(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.

From the reviews:

Describes in detail the standard, analytical methodologies that are used to evaluate the safety of a new compound or a particular compound's 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, Doody's Review Service, April, 2011)


Part I: General Toxicology

1. Developing Combination Drugs in Preclinical Studies
Alberto Lodola

2. Preclinical Evaluation of Juvenile Toxicity
Paul C. Barrow, Stéphane 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
José 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, Agnès 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-François Lévesque, 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 Léonard, 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, Björn Riefke, Götz 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


Titel: Drug Safety Evaluation
Untertitel: Methods and Protocols
EAN: 9781493956692
ISBN: 1493956698
Format: Kartonierter Einband
Herausgeber: Humana Press
Genre: Medizin
Anzahl Seiten: 448
Gewicht: 837g
Größe: H254mm x B178mm x T24mm
Jahr: 2016
Auflage: Softcover reprint of the original 1st ed. 2011

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