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
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