Table of Contents
Research Update Office of Testing and Research Product Quality Research Institute, Inc.
OTR Organization
Mission
OTR Program Focus
Collaborations
OTR Topics
Background: Sorbitol
Effect on Gastro-Intestinal Transit Time (minutes)
Sorbitol/Mannitol: Impact on Bioavailability
Study Objectives
Formulations
Results: Average Profiles (n=40)
Results: Average Profiles (n=20)
Bioequivalence: Average Criteria
Individual Bioequivalence
Results
Subject-by-Formulation Interaction?
Conclusion
Generalization of these results?
Metoprolol Study: Preliminary Data
PQRI Product Quality Research Institute
Founding Members
PQRI Recommendations to FDA
FDA
Safety, Efficacy and Product Quality Linkages
Regulatory Hypothesis Approach
Desired Outcome
Different Perspectives
FDA Perspective: CMC
Major Reasons For “Recall”*
FDA Perspective: CMC
FDA Perspective: Biopharm
Current Research Focus
Rational Approaches for Powder Blend Uniformity Testing for Solid Dosage
Blend Uniformity Testing
Blend Uniformity Testing
Current Research Focus
Current Research Focus
Current Research Focus
Additional Information
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