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Preclinical Development Handbook
Toxicology
edited by
Shayne Cox Gad

Preclinical Development Handbook: Toxicology gives the professional pharmaceutical scientist a basic and comprehensive tool to facilitate the preclinical development process by bringing together, in one resource an overview of the preclinical process along with a compendium of methods and techniques that need to be considered when developing a new drug.

The book details steps in the preclinical process including:

  • prioritizing and optimizing leads
  • toxicity
  • pharmacogenomics
  • modeling
  • regulations

Preclinical Development Handbook: Toxicology includes problems that are encountered, solutions to these problems, and limitations of various methods and techniques used in determining the safety and efficacy of a drug at this stage.

Contents

  1. Preclinical Drug Development Planning
  2. Use of Project Teams in Preclinical Development
  3. Relationship between Animal Models and Clinical Research: Using Mucositis as a Practical Example
  4. Bacterial Mutation Assay
  5. In Vitro Mammalian Cell Mutation Assays
  6. In Vitro Mammalian Cytogenetic Tests
  7. In Vivo Genotoxicity Assays
  8. Repeat Dose Toxicity Studies
  9. Irritation and Local Tissue Tolerance Studies in Pharmacetical Safety Assessment
  10. Safety Assessment Studies: Immunotoxicity
  11. Immunotoxicity Testing: ICH Guideline S8 and Related Aspects
  12. Reproductive and Developmental Toxicology
  13. Carcinogenicity Studies
  14. Toxicokinetics: An Integral Component of Preclinical Toxicity Studies
  15. In Vitro Toxicokinetics and Dynamics: Modeling and Interpretation of Toxicity Data
  16. Toxicologic Pathology
  17. Secondary Pharmacodynamic Studies and In Vitro Pharmacological Profiling
  18. Current Practices in Safety Pharmacology
  19. Safety Assessment of Biotechnology-Derived Therapeutics
  20. Preclinical Development of Protein Pharmaceuticals: An Overview
  21. The Pharmacogenomics of Personalized Medicine
  22. Genomics
  23. Proteomics
  24. Toxicogenomics in Preclinical Development
  25. Toxicoproteomics: Preclinical Studies
  26. Regulatory Considerations
  27. Regulatory Issues in Preclinical Safety Studies (U.S. FDA)
  28. Selection and Utilization of CROs for Safety Assessment
  29. Auditing and Inspecting Preclinical Research and Compliance with Good Laboratory Practice (GLP)
  30. Drug Impurities and Degradants and Their Safety Qualification
  31. Bridging Studies in Preclinical Pharmaceutical Safety Assessment

Index

Also available:
Preclinical Development Handbook Volume 1: ADME and Biopharmaceutical Properties
Preclinical Development Handbook 2-Volume Set

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Preclinical Development Handbook
Toxicology
by Shayne Cox Gad

2008 1,059 pages $194.00 + shipping
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