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.On the whole, there is no single stability-indicating assay or parameter that profiles the stability characteristics of a biotechnological/biological product. ... At the time of submission, applicants should have validated the methods that comprise the stability-indicating profile, and the data should be ... For the purpose of stability testing of the products described in this guideline, purity is a relative term. Becauseanbsp;...
|Title||:||Handbook of Preformulation|
|Author||:||Sarfaraz K. Niazi|
|Publisher||:||CRC Press - 2006-09-18|