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Pediatrics / Adolescence / Human development / Puberty / Fulvestrant / Menopause / Precocious puberty / Clinical trial / Medicine / Health / Chemistry


21344 Fulvestrant Statistical PREA
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City

Reference / /

Company

SPECIAL/SUBGROUP / AstraZeneca Pharmaceuticals LP / Parameter Subgroup / Other Special/Subgroup / ITT / /

Country

Germany / France / Russia / United States / Italy / United Kingdom / /

Event

FDA Phase / /

Facility

National Center / /

IndustryTerm

treatment of hormone receptor positive metastatic breast cancer / /

MedicalCondition

positive metastatic breast cancer / disease / rare disease / McCune-Albright syndrome / progressive precocious puberty / precocious puberty / /

Organization

Division of Metabolic and Endocrine Products / Pubic Tanner Staging / FOOD AND DRUG ADMINISTRATION / National Center for Health Statistics / Biometrics Division / DEPARTMENT OF HEALTH AND HUMAN SERVICES / Medical Division / /

Person

Dragos Roman / Ali Mohamadi / Todd Sahlroot / Cynthia Liu / Jennifer Johnson Keywords / /

Position

Statistical Team Leader and Deputy Director of Biometrics / local consultant / Medical Team Leader Project manager / /

Product

triad / Faslodex / Nolvadex / Clinical Studies Faslodex™ (fulvestrant) injection / S-013 / Overview Faslodex™ (fulvestrant) injection / D6992C00044 / /

Technology

pharmacokinetics / /

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