Reinhard Baildon, M.D.

10/17/01


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Table of Contents

Reinhard Baildon, M.D.

Voriconazole

PPT Slide

Voriconazole Development Program

Sponsor Section

Voriconazole

Voriconazole Clinical Program

Voriconazole

Voriconazole

Esophageal Candidiasis Study (305) MIC Data for Candida Isolates

Esophageal Candidiasis Study (305) Clinical Isolate Susceptibilities (N = 633)

Global Comparative Aspergillosis Study (307/602) MIC Data for Aspergillus Isolates

Voriconazole In Vivo Model

Neutropenic Guinea Pig Model Disseminated Invasive Aspergillosis

Voriconazole

Voriconazole

Voriconazole Clinical Pharmacology

Voriconazole

Voriconazole Tissue Distribution in Animals

Voriconazole Metabolism and Excretion

Voriconazole Non-linear Pharmacokinetics

Voriconazole Loading Dose Regimen (Study 247)

Voriconazole Factors Influencing Pharmacokinetic Variability

Voriconazole Factors Influencing Pharmacokinetic Variability

Voriconazole Factors Influencing Pharmacokinetic Variability

Voriconazole Factors Influencing Pharmacokinetic Variability

Voriconazole Factors Influencing Pharmacokinetic Variability

Voriconazole Factors Influencing Pharmacokinetic Variability

Voriconazole Factors Influencing Pharmacokinetic Variability

Voriconazole Factors Influencing Pharmacokinetic Variability

Voriconazole Drug-drug Interactions

Voriconazole Drug-drug Interactions: Contraindications

Voriconazole Drug-drug Interactions: Dose Adjustment

Voriconazole Drug-drug Interactions: Dose Adjustment

Voriconazole Drug-drug Interactions

Voriconazole Summary of Pharmacokinetics

Voriconazole

Voriconazole Factors Affecting Dose Selection

Voriconazole Dose Selection

Voriconazole Dosage and Administration

PPT Slide

Voriconazole

Voriconazole Safety Database

Voriconazole Overall Patient Exposure

Voriconazole Target Population

Overview of Safety Presentation

Voriconazole Deaths - Safety Populations

Global Comparative Aspergillosis Study (307/602) Time to Death (Safety Population)

Discontinuations Due to Adverse Events and Laboratory Abnormalities

Healthy Volunteers Most Frequent Voriconazole Adverse Events

Global Comparative Aspergillosis Study (307/602) Most Frequent Voriconazole Adverse Events

Empirical Therapy Study (603/MSG42) Most Frequent Voriconazole Adverse Events

Esophageal Candidiasis Study (305) Most Frequent Voriconazole Adverse Events

Voriconazole Special Safety Topics

Voriconazole Frequency of Abnormal Vision

Descriptions of Visual Disturbances

NDA Therapeutic Studies Distribution of Time to First Visual Disturbance

Multiple Dose Visual Function Study (1004)

Multiple Dose Visual Function Study (1004)

Multiple Dose Visual Function Study (1004)

Multiple Dose Visual Function Study (1004) Left Eye Visual Acuity - Change from Baseline

Esophageal Candidiasis Study (305) Visual Acuity - Change from Baseline*

Visual Disturbances: Conclusions

Voriconazole Special Safety Topics

Multiple Dose Escalation IV/Oral Switch Study (230) Hepatic Function in Volunteers

Multiple Dose Escalation IV/Oral Switch Study (230) Hepatic Function in Volunteers

Voriconazole Frequency of Abnormal ALT (> 3 x ULN)

Voriconazole Frequency of Abnormal Total Bilirubin (> 1.5 X ULN)

Frequency of Hepatic Failure and Death Serious Adverse Events

Hepatic Failure and Death Causal Relationship not Excluded by Investigator or Sponsor

Hepatic Conclusions

Voriconazole Special Safety Topics

Descriptions of Skin Adverse Events

Frequency of Rash

Frequency of Photosensitivity Reaction

Skin Conclusions

Voriconazole Special Safety Topics

Other Safety Issues

Voriconazole Sudden Cardiac Death Patient 603/1485

In vitro Studies of Voriconazole and Ketoconazole

Phase 1: Frequency of Borderline and Abnormal QTc (Fridericia Correction)

Voriconazole Phase I ECG Analysis QTc (Fridericia) 1 hour post single dose

Anaphylactoid Reactions

Empirical Therapy Study (603/MSG42) Infusion Related Reactions (MITT) - All*

Other Safety Issues

Safety Conclusions

Voriconazole

Author: Hitchcock_ca