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U.S. Department of Health and man Services Food and drug Administration Center for dose Evaluation and Research office of Translational Sciences Office of Biostatistics statistical Review and Evaluation C LI NICAL S TUDI ES NDA/Serial number: Drug Name: Proposed Indication(s): applicant: Date(s): Review Priority: biometry Division: Statistical reader: Secondary Reviewer: Statistics executive program: Medical Division: clinical Team: Project animal trainer: N21-658/N000 Ciclesonide metered dose inhaler (ALVESCOTM) upkeep treatment of asthma as prophylactic therapy in patients age of age and older Nycomed Inc. true July 10, 2007 Standard Division of biometrics II/Office of Biostatistics Qian H. Li, Sc.D. Ruthanna Davi doubting Thomas Permutt, Ph.D (Division Director) Division of Pulmonary and supersensitized reaction Products Carol Bosken, M.D. Lydia Gilbert-McClain, M.D. Badrul A Chowdhury, M.D., Ph.D (Medical Division Director) Colette Jackson Keywords: NDA review, Growth Study  turn off 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 understructure ............................................................................................................... 4 OVERVIEW ....................................................................................................................................................4 data SOURCES..............................................................................................................................................4 STATISTICAL rating OF STUDY 343...If you want to outsmart a full essay, put in it on our website: Ordercustompaper.com

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