U.S. Department of Health and Human Services Food and medicine Administration Center for drug Evaluation and Research province 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 division: Statistical lecturer: Secondary Reviewer: Statistics Supervisor: aesculapian section: clinical Team: Project Manager: N21-658/N000 Ciclesonide metered demigod inhaler (ALVESCOTM) alimentation treatment of asthma as contraceptive device therapy in patients years of age and older Nycomed Inc. Received July 10, 2007 modular parting 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 : 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 incoming ........................................................................................................ ....... 4 OVERVIEW .......................! .............................................................................................................................4 data SOURCES..............................................................................................................................................4 STATISTICAL EVALUATION OF STUDY 343...If you privation to get a full essay, order it on our website: BestEssayCheap.com
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