Drugs From Discovery to Approval presents a clear, step-by-step overview of the entire process.

Features:

• A helpful listing of current FDA and European guidelines
• A special section on regulatory authorities and processes in Japan and China
• Rich illustrations throughout, including more than ninety figures and tables
• Useful appendices on the history of drug discovery and development
• Representative examples of drug mechanisms in action

Contents

1. Introduction
2. Drug Discovery: Targets and Receptors
3. Drug Discovery: Small Molecule Drugs
4. Drug Discovery: Large Molecule Drugs
5. Drug Development and Preclinical Studies
6. Clinical Trials
7. Regulatory Authorities
8. Regulatory Applications
9. Good Manufacturing Practice: Regulatory Requirements
10. Good Manufacturing Practice: Drug Manufacturing
11. Future Perspectives

Appendices

• History of Drug Delivery and Development
• Cells, Nucleic Acids, Genes and Proteins
• Selected Drugs and Their Mechanisms of Action
• Pharmacology/Toxicology Review Format

Acronyms
Glossary
Index

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