Clinical Pharmacology Overview From the Antiviral Perspective

7/31/00


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Table of Contents

Clinical Pharmacology Overview From the Antiviral Perspective

Outline

Terminology

Terminology

Terminology

Outline

Bioequivalence

Bioequivalence

Determining Bioequivalence

Determining Bioequivalence

Bioequivalence

Bioequivalence: Assumptions

Bioequivalence

Bioequivalence- Flexibility Example

Bioequivalence- Flexibility Example

Outline

Scenarios with Antiretroviral Drugs

New Formulations

New Formulations

New Formulations

New Formulations

New Formulations

Change in Dosing Regimen

Change in Dosing Regimen Example- Nelfinavir

Change in Dosing Regimen Example- Nelfinavir

Change in Dosing Regimen Example- Nelfinavir

Change in Dosing Regimen

Change in Dosing Regimen

Change in Dosing Regimen

Change in Dosing Regimen

Change in Dosing Regimen

Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biologic Products

Drug Interactions

Drug Interactions

Drug Interactions- Typical

Drug Interactions

Drug Interactions

Drug Interactions

Drug Interactions

Drug Interactions PK Enhancers

Drug Interactions PK Enhancers

Drug Interactions PK Enhancers

Drug Interactions PK Enhancers

Drug Interactions PK Enhancers

Drug Interactions PK Enhancers

Pediatric Dosing

Pediatric Dosing

Pediatric Dosing

Pediatric Dosing Example: Nelfinavir

Scenarios Summary of Potential Issues

Scenarios Summary of Potential Issues

Scenarios Summary of Potential Issues

Outline

Using PK/PD

Using PK/PD

PK/PD Considerations Pharmacometrics Consultation

Pharmacokinetic Considerations

Pharmacokinetic Considerations

Pharmacokinetic Considerations

Pharmacokinetic Considerations

Pharmacokinetic Considerations

Pharmacokinetic Considerations

Pharmacokinetic Considerations

Pharmacodynamic Considerations

Additional Considerations

PK/PD Considerations

Outline

Standard of Evidence

Standard of Evidence

Author: Kellie Reynolds