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U.S. Department of Health and Human Services Food and medicine Administration Center for drug Evaluation and Research state 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 divergence: Statistical lecturer: Secondary Reviewer: Statistics Supervisor: medical examination parting: clinical Team: Project Manager: N21-658/N000 Ciclesonide metered dose inhaler (ALVESCOTM) alimentation treatment of asthma as refuge therapy in patients years of age and older Nycomed Inc. Received July 10, 2007 exemplification 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: N DA 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 design ............................................................................................................. .. 4 OVERVIEW ............................! ........................................................................................................................4 data SOURCES..............................................................................................................................................4 STATISTICAL EVALUATION OF STUDY 343...If you involve to get a full essay, order it on our website: BestEssayCheap.com

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