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Pharmaceutical sciences / Neuraminidase inhibitors / Pandemics / Acetamides / Oseltamivir / Flu pandemic / Influenza / Clinical trial / Pharmacometrics / Health / Pharmacology / Medicine


CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 021246Orig1s045 and 021087Orig1s062
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Document Date: 2013-04-08 10:07:49

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File Size: 1,72 MB

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City

Dallas / Reference / /

Company

IgG / Transplacentally / Sponsor Hoffmann La Roche Inc. / Hoffmann La Roche Inc. / /

Country

United States / /

Event

FDA Phase / /

Facility

Medical Center Parkland Health / University of Texas Southwestern Medical Center / /

IndustryTerm

Chemical formula / chemical name / /

MedicalCondition

pneumonia / influenza infection / swine flu / bronchiolitis / influenza / croup / /

Organization

University of Texas Southwestern Medical Center at Dallas / office of Scientific Investigations / Division of Bioequivalence / office of Clinical Pharmacology/Divisions / Pharmacometrics OND Division Division of Antivial Products / FDA / OCP Division / OND Division / /

Person

Jenny H. Zheng / SHIRLEY K SEO / Yaning Wang / Shirley Seo / Pharmacometrics Reviewer Jee Eun Lee / Sanchez / /

Position

Team Leader / EXECUTIVE / Clinical Pharmacology Team Leader / General / /

Product

Tamiflu / Siemens S45 Cellular Phone / S45 / Administration Oral / Executive Summary Tamiflu® (oseltamivir) / Strength(s) Powder / /

PublishedMedium

the Clinical Pharmacology review / the OSI review / /

Technology

pharmacokinetics / antibodies / pharmacodynamics / Simulation / /

SocialTag