Interpersonal

U.S. Department of Health and Human Services Food and drug Administration Center for medicine Evaluation and Research responsibleness 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 breakdown: Statistical lecturer: Secondary Reviewer: Statistics Supervisor: medical exam grade: clinical Team: Project Manager: N21-658/N000 Ciclesonide metered venereal disease inhaler (ALVESCOTM) alimentation treatment of asthma as hindrance therapy in patients years of age and older Nycomed Inc. Received July 10, 2007 step fraction 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 Keywo rds: 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 establishment ................................................................................................ ............... 4 OVERVIEW ...............! .....................................................................................................................................4 data SOURCES..............................................................................................................................................4 STATISTICAL EVALUATION OF STUDY 343...If you expect to get a full essay, order it on our website: BestEssayCheap.com

If you want to get a full essay, visit our page: cheap essay