Table of Contents
Challenges of Pharmacokinetic/Pharmacodynamic Assessments in Pediatric Oncology
Outline
Pharmacology Studies EnhanceDevelopment 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 StudiesEnhance 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
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Author: Clinton Stewart, Pharm.D.
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