Drug Transfer into Milk: Clinical Methods & Issues

7/20/01


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Table of Contents

Drug Transfer into Milk: Clinical Methods & Issues

Outline

Neonate Exposure via Milk

Clinical Study Design Issues

Single Time Point vs AUC Approach

Clinical Study Design Issues

Models

Physiochemical Predictive Models

Factors Influencing M/S

Physiochemical Model Prediction

Cell Culture Models

Animal Models

M/S Prediction

Active Transport Issues

Cimetidine in Human Milk

PPT Slide

Transporters

Neonatal Exposure Issues

Route of Drug Clearance

Developmental Expression of Cytochrome P450

Nursing vs Dosing Interval

Neonatal Exposure

Conclusions

Author: PJ McNamara