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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 handbook 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.
Synopsis: Preformulation comprises the physical, chemical, and biological studies needed to characterize a drug substance to enable the proper design of a drug product, while making a drug product effective is dealt with in the formulation studies phases. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development. The goals of preformulation studies are to choose the correct form of a drug substance, evaluate its physical properties, and generate a thorough understanding of the material's stability under various conditions, in order to determine the optimal drug delivery system. This title provides detailed discussions 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.
Title: Handbook of Preformulation: Chemical, ...
Publisher: Informa Healthcare
Publication Date: 2006
Binding: Hardcover
Condition: Good