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

click here to see books of related interest