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U.S. Department of Health and Human Services Food and window glass Administration Center for drug Evaluation and Research certificate of indebtedness 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 element: Statistical lecturer: Secondary Reviewer: Statistics Supervisor: aesculapian naval division: clinical Team: Project Manager: N21-658/N000 Ciclesonide metered dose inhaler (ALVESCOTM) alimentation treatment of asthma as hinderance therapy in patients years of age and older Nycomed Inc. Received July 10, 2007 pattern course of instruction 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 Directo r) Colette Jackson Keywords: NDA 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 gateway ........................................................................... .................................... 4 OVE! RVIEW ....................................................................................................................................................4 data SOURCES..............................................................................................................................................4 STATISTICAL EVALUATION OF STUDY 343...If you compulsion to get a full essay, order it on our website: BestEssayCheap.com

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