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:

• SurvivaI
• Complete Remission
• Duration of Remission

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