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U.S. Department of Health and Human Services Food and drug Administration Center for do drugs Evaluation and Research debt instrument of Translational Sciences Office of Biostatistics Statistical Review and Evaluation C LI NICAL S TUDI ES NDA/Serial Number: Drug Name: Proposed Indication(s): applicator: Date(s): Review Priority: biometrics instalment: Statistical lecturer: Secondary Reviewer: Statistics Supervisor: checkup instalment: clinical Team: Project Manager: N21-658/N000 Ciclesonide metered panelling inhaler (ALVESCOTM) alimentation treatment of asthma as safety therapy in patients years of age and older Nycomed Inc. Received July 10, 2007 measuring member of Biometrics II/Office of Biostatistics Qian H. Li, Sc.D. Ruthanna Davi Thomas Permutt, Ph.D (Division Director) Division of Pulmonary and allergic reaction Products Carol Bosken, M.D. Lydia Gilbert-McClain, M.D. Badrul A Chowdhury, M.D., Ph.D (Medical Division Director) Colette Jackson Keywords: ND A review, Growth Study Table of Contents 1. 1.1 1.2 2. 2.1 2.2 3. 3.1 3.2 4 5 EXECUTIVE SUMMARY ................................................................................................. 3 CONCLUSIONS .................................................................................................................................

..............3 STATISTICAL ISSUES AND FINDINGS .............................................................................................................3 invention ............................................................................................................... 4 OVERVIEW ...... ............................................! ..................................................................................................4 data SOURCES..............................................................................................................................................4 STATISTICAL EVALUATION OF STUDY 343...If you demand to get a full essay, order it on our website: BestEssayCheap.com

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