Pharmaceutical Bioequivalence examines how the rate and extent of drug absorption are a function of many factors, including the site of administration, the physiochemical characteristics of the compound, and the dosage form.

Contents

• Bioequivalence and Its Determination Bioequivalence and Therepeutic Equivalence
• Study Design for the Assessment of Bioavailability and Bioequivalence
• Statistical Criteria
• Influence of Disease on Bioavailability
• Factors Influencing Bioavailability and Bioequivalence
• The Role of Intestinal Metabolism on Bioavailability
• Bioavailability of Transdermal and Topical Dosage Forms
• In Vitro Methods to Determine Bioavailability: In Vitro-In Vivo Correlations
• Pharmacodynamic Models Animal Models for Oral Drug Absorption
• Interspecies Scaling in Pharmacokinetics
• Pharmacodynamic Models in Bioequivalence
• Perspectives of Regulatory Agencies, Worldwide, on Bioequivalence Testing Bioequivalence: A United States Regulatory Perspective
• Bioequivalence: A Canadian Regulatory Perspective
• Bioequivalence: A European Community Regulatory Perspective
• Bioavailability and Bioequivalence: An Australian Perspective
• Bioequivalence: A Nordic Perspective

Index

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