Liposome Drug Products: Bioavailability and Bioequivalence Issues

7/30/01


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Table of Contents

Liposome Drug Products: Bioavailability and Bioequivalence Issues

Bioavailability

Bioequivalence

Bioavailability/Bioequivalence

Types of Evidence to Establish BA/BE

Prerequisites for Using PK Method to Assess BA/BE

Classification of Liposome Drug Products Based on MPS

MPS Uptake Liposomes

MPS Avoidance Liposomes

The Key Issues

MPS Uptake: Suggested Scheme for BA/BE Determination

MPS Avoidance: Suggested Scheme for BA/BE Determination

Combined Scheme for Determination of BA/BE

Acknowledgements

Author: CDER USER