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Idarubicin

Idamycin Product Monograph



TABLE OF CONTENTS

HISTORICAL PERSPECTIVE

PRECLINICAL PHARMACOLOGY
Description
Mechanism of Action
In Vitro Pharmacologic Activity
In Vivo Pharmacologic Activity
Safety Pharmacology

TOXICOLOGY
Acute Toxicity
Subchronic Toxicity
Other Toxicology Studies
Reproduction
Mutagenicity

PRECLINICALDISPOSITION
Tissue Distribution
Metabolism
Excretion
Summary

HUMAN PHARMACOKINETICS
Clinical Pharmacology
Pharmacokinetic Evaluations in Adult Leukemia Patients
Human Pharmacokinetics in Pediatric Patients
Human Pharmacokinetics in Patients with Solid Tumors
Summary

CLINICAL STUDIES
Overview of Clinical
Eligibility and Efficacy Criteria
Results:
Summary of Foreign Controlled Studies
Summary of U.S. Uncontrolled Studies
Summary of Foreign Uncontrolled Studies
Safety Profiles of U S. Controlled Studies
Summary

GUIDELINES FOR DOSING & ADMINISTRATION
Dosage Regimen
Preparation and Administration

FULL PRESCRIBING INFORMATION

HOSPITAL FORMULARY

BIBLIOGRAPHY


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