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Antiviral Drugs Advisory Committee

April 24, 2007

Slides

FDA Introductory Remarks Katie Laessig, M.D. Medical Team Leader, Division of Antiviral Products, FDA (ppt) (htm)

Applicant Presentation

Introduction, Background and Overview of Maraviroc, Michael Dunne, M.D., Therapeutic Area Head, Infectious Diseases, Pfizer (pdf)

Clinical Efficacy, Howard Mayer, M.D., Global Clinical Leader, Pfizer (pdf)

Safety and Toleration, Steve Felstead, M.D., Maraviroc Team Leader, Pfizer (pdf)

In Vitro and In Vivo Tropism and Resistance Evaluation, Mike Westby, Ph.D. Virology Team Leader, Pfizer (pdf)

Medical Need and Place in HIV Armamentarium, Dan Kuritzkes, M.D., Brigham and Women's Hospital, Boston (ppt) (htm)

Conclusions,  Mike Dunne, M.D. (pdf)

FDA Presentation

Clinical Safety and efficacy, Scott Proestel, MD, Medical Officer, Division of Antiviral, Products, CDER, FDA (ppt) (htm)

Exposure-Response Modeling, Pravin Jadhav, PhD, Pharmacometrician/Clinical, Pharmacologist, Office of Clinical, Pharmacology, CDER, FDA (ppt) (htm)

Tropism and Resistance, Lisa Naeger, PhD, Clinical Virologist, Division of Antiviral Products, CDER, FDA (ppt) (htm)

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