Research Update Office of Testing and Research Product Quality Research Institute, Inc.

4/26/01


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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

Author: Ajaz S Hussain PhD