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Pharmaceutical Issues in Drug Development
Umesh V. Banakar
St. Louis College of Pharmacy
St. Louis, Missouri
Michael C. Makoid
Creighton University
Omaha, Nebraska
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I. Introduction
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II. Role of Excipients in Drug Development
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A. General Characteristics
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B. Performance Characteristics
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III. Dosage Form Design
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A. Dissolution Testing
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IV. In Vitro-In Vivo Correlation
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A. Basics of In Vivo-In Vitro Correlations
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B. What Parameters Should Be Considered in In Vivo-In Vitro Correlations?
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C. System Response Correlation Concept
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D. Discussion on System Response Correlation Concept
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References
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