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Titlebook: Biopharmaceutics Applications in Drug Development; Rajesh Krishna,Lawrence Yu Book 2008 Springer-Verlag US 2008 absorption.bioequivalence.

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Introduction to Biopharmaceutics and its Role in Drug Development,of preparing, using, and administering drugs to living organisms or tissues. Inherent in the concept of biopharmaceutics as discussed here is the interdependence of biological aspects of the living organism (the patient) and the physical–chemical principles that govern the preparation and behavior of the medicinal agent or drug product.
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,In Vitro–In Vivo Correlation in Dosage Form Development: Case Studies,ferent ways (Li ., 2005). Through the establishment of a definitive relationship between certain physicochemical properties of a dosage form with the . appearance of its active component, one can establish . testing criteria which will predict, its . performance.
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Einleitung: Laser in der Umweltmeßtechniking from initial clinical testing to final approval has remained disappointingly low. Greater than 90% of the compounds entering Phase-I clinical testing fail to reach the patients and as high as 50% entering Phase-III do not make the cut (Kola and Landis, 2004).
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R. Bombach,B. Hemmerling,W. Kreutnerlity; (2) present examples from FDA-approved drug product labeling to show how food effects are considered in optimizing therapy; (3) distinguish between food effects on drug substance versus drug product; and (4) explain the role of food-effect studies in new and generic drug development.
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A Biopharmaceutical Classification System Approach to Dissolution: Mechanisms and Strategies,tors the impact of environmental storage conditions and manufacturing process upon the rate of drug release from the dosage form. These sensitivities have led to the use of the dissolution test as a measure of formulation bioperformance.
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