Individual Bioequivalence: Background and Concepts

12/3/01


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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

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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

Author: FDA\CDER