544 pages | 12 Color Illus. | 68 B/W Illus.
Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development.
Entirely focused on preformulation principles, this fully revised and updated Handbook of Preformulation: Chemical, Biological, and Botanical Drugs, Second Edition provides detailed descriptions of preformulation methodologies, gives a state-of-the-art description of each technique, and lists the currently available tools useful in providing a comprehensive characterization of a new drug entity.
Preface to the Second Edition
Other Selected Books by Author
1. Drug Discovery Trends
2. Intellectual Property Considerations
3. The Scope of Preformulation Studies
4. Dissociation, Partitioning, and Solubility
5. Release, Dissolution, and Permeation
6. Solid-State Properties
7. Dosage Form Considerations in Preformulation
8. Chemical Drug Substance Characterization
9. Characterization of Biopharmaceuticals
10. Botanical Drugs