Table of Contents
Individual Bioequivalence: Background and Concepts
Individual Bioequivalence Advantages
Individual Bioequivalence Assessment Distance Concept
Individual Bioequivalence
Subject-by-Formulation Interaction
Sources of S x F Interaction
Verapamil Immediate Release Age-based SxF Interaction
Calcium Channel Blocker Gender-based S x F Interaction
Interpretation of S x F Interaction
Approach 1
PPT Slide
Individual Bioequivalence Criterion
Mixed-Scaling Approach
Constraint on Mean Difference
Replicate Design Studies: NDA’s and FDA Database
PPT Slide
PPT Slide
PPT Slide
PPT Slide
PPT Slide
PPT Slide
FDA Contract Studies
Interplay of Drugs and Excipients
Excipient Effect Hypothesis
Ranitidine Levels
Metoprolol Levels
Ranitidine in Sucrose vs. Sorbitol Solution Subject-by-Formulation Interaction
Methylphenidate
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