ABSTRACT
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.
Features:
- Addresses the preformulation studies of three different types of new active entities - chemical, biological, and botanical, which is the latest established class of active ingredient classified by the FDA
- Illustrates the activities comprised in preformulation studies and establishes a method of tasking for drug development projects
- Includes extensive flow charts for characterization decision making
- Gives extensive theoretical treatment of principles important for testing dissolution, solubility, stability, and solid state characterization
- Includes over 50% new material
