Informa Healthcare | 1 edition | September 18, 2006 | ISBN: 9780849371936 | PDF | English | 6 Mb | 446 pages
"Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance..."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.
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