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U.S. Department of Health and homo Services Food and drug Administration Center for dose Evaluation and Research state of Translational Sciences Office of Biostatistics statistical Review and Evaluation C LI NICAL S TUDI ES NDA/Serial get down: Drug Name: Proposed Indication(s): applicant: Date(s): Review Priority: biometrics Division: Statistical referee: Secondary Reviewer: Statistics supervisor: Medical Division: clinical Team: Project managing director: N21-658/N000 Ciclesonide metered dose inhaler (ALVESCOTM) provender treatment of asthma as prophylactic therapy in patients historic period of age and older Nycomed Inc. standard July 10, 2007 Standard Division of biometry 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  remit of Contents 1. 1.1 1.2 2. 2.1 2.2 3. 3.1 3.2 4 5 executive director SUMMARY ................................................................................................. 3 CONCLUSIONS .................................................................................................................................

..............3 STATISTICAL ISSUES AND FINDINGS .............................................................................................................3 incoming ............................................................................................................... 4 OVERVIEW ....................................................................................................................................................4 data SOURCES..............................................................................................................................................4 STATISTICAL rating OF STUDY 343...If you want to get a full essay, holy order it on our website: Ordercustompaper.com

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