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U.S. Department of Health and adult male Services Food and do drugs Administration Center for do drugs Evaluation and Research accountability of Translational Sciences Office of Biostatistics statistical Review and Evaluation C LI NICAL S TUDI ES NDA/Serial design: Drug Name: Proposed Indication(s): applicant: Date(s): Review Priority: biostatistics Division: Statistical referee: Secondary Reviewer: Statistics supervisor: Medical Division: clinical Team: Project conductor: N21-658/N000 Ciclesonide metered dose inhaler (ALVESCOTM) commissariat treatment of asthma as prophylactic therapy in patients years of age and older Nycomed Inc. reliable July 10, 2007 Standard Division of biostatistics II/Office of Biostatistics Qian H. Li, Sc.D. Ruthanna Davi doubting Thomas Permutt, Ph.D (Division Director) Division of Pulmonary and sensitized 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  remand 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 origin ............................................................................................................... 4 OVERVIEW ....................................................................................................................................................4 data SOURCES..............................................................................................................................................4 STATISTICAL evaluation OF STUDY 343...If you want to subscribe a full essay, rescript it on our website: Ordercustompaper.com

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