Challenges of Pharmacokinetic/Pharmacodynamic Assessments in Pediatric Oncology

11/30/01


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Table of Contents

Challenges of Pharmacokinetic/Pharmacodynamic Assessments in Pediatric Oncology

Outline

Pharmacology Studies Enhance Development of Anticancer Drugs

Two Commercially Available Topoisomerase I Inhibitors For Use In Pediatric Oncology: Topotecan and Irinotecan

Initial Clinical Trials with Topoisomerase I Inhibitors in Children with Cancer

Initial Clinical Trials with Topoisomerase I Inhibitors in Children with Cancer

Initial Clinical Trials with Topoisomerase I Inhibitors in Children with Cancer

Initial Clinical Trials with Topoisomerase I Inhibitors in Children with Cancer

Comparison of Results from Adult and Pediatric Phase I Studies for the Topoisomerase I Inhibitors

Outline

Application of Nonclinical PK/PD Studies Enhance Anticancer Drug Development

PPT Slide

Summary of Topoisomerase I Antitumor Efficacy Studies Conducted in the Xenograft Model

Use of the Nonhuman Primate Model

Outline

Rationale for Pharmacokinetically Guided Dosing of Anticancer Drugs

Rationale for Pharmacokinetically Guided Dosing in Children with Cancer

Selected Criteria for Pharmacokinetically Guided Dosing

Application of Pharmacokinetic Studies to Optimize Topotecan Therapy: Design Considerations

PPT Slide

Lessons Learned from Pharmacokinetically Guided Topotecan Clinical Trials

Lessons Learned from Pharmacokinetically Guided Topotecan Clinical Trials

Outline

Design Issues for Molecular Target-Based Anticancer Drugs in Children

Challenges in Pharmacokinetic/Pharmacodynamic Assessments in Pediatric Oncology

Author: Clinton Stewart, Pharm.D.