PPT-Analytical Similarity Assessment: Practical Challenges and Statistical Perspectives

Richard Montes PhD Hospira a Pfizer company Biosimilars Pharmaceutical Sciences Statistics Presentation Outline Background on demonstration of biosimilarity Tier 1 Equivalence Testing. An analytical model is presented to assess the signal degradation The impairments due to XPM are related to a Qfactor The presented formulas are examined for different dispersion compensation schemes and also mixedfiber systems The analytical models Practical Technology. Developing qualifications . - drivers. Progression. – provide progression from . Es. & . Os. and maximise continuity between levels . More open and flexible requirements – . DAUBERT. :. AVOIDING AND EXPLOITING . “ANALYTICAL GAPS”. IN EXPERT TESTIMONY. Richard O. Faulk. Chair, Litigation Department. Gardere Wynne Sewell, LLP. rfaulk@gardere.com. (713) 276-5651. THE . DAUBERT. these theories have explanatory power domains partially role of relational judgments. Previous structural and aspects of notion of relational similarity by the fact that and her some ways there is in Practicals. Dr Alex Holmes. ASE 2016. Thursday 1500-1600 Arts LR6 . How can you best assess practicals at KS3? . Objectives of this workshop. Methods of assessing practical work. Identifying strategies for practical work assessment. Practicals. Dr Alex Holmes. ASE 2016. Thursday 1500-1600 Arts LR6 . How can you best assess practicals at KS3? . Objectives of this workshop. Methods of assessing practical work. Identifying strategies for practical work assessment. of Binaries. Yaniv David. , Nimrod . Partush. , . Eran. . Yahav. . @. *. The research leading to these results has received funding . from the . European Union's - Seventh Framework . Programme. (FP7) under grant agreement n° . Intro. Introductions. Value. Perspectives. Challenges. Discussion. Lead Into . Gold. : . The Alchemy of Open Data. . . August 2, 2010. TASSCC Annual Conference. Agenda. Janet Gilmore. 1. 2. Janet Gilmore. products. Meiyu Shen, Lixin Xu. Center for Drug Evaluation and Research, . U.S. . Food and Drug . Administration. This presentation reflects the views of the author and should not be construed to represent FDA’s views or policies. A review . of Statistical capacity . assessments. François . Fonteneau. . (PARIS21. ). Outline. Purpose and methodology. Results. Possible next steps. Check . what. . Assessments. . actually. . measure. How to Conduct Effective Assessment When Nobody Wants to They Can’t Agree What to B ut We Have to The history of a large community college English Department’s struggle to implement a district wide assessment program. Quiz. Which pair of words exhibits the greatest similarity?. 1. Deer-elk. 2. Deer-horse. 3. Deer-mouse. 4. Deer-roof. Quiz Answer. Which pair of words exhibits the greatest similarity?. 1. Deer-elk. 2. Deer-horse. Helena Geys. 1. , Fetene Tekle. 1. , Maxim Nazarov. 2. June 13, 2017. 1: Johnson & Johnson. 2: Open Analytics. Objectives. Toxicology:. Prove the harmlessness of a test substance. Genotoxicology. Sept 16, 2015. W. Heath Rushing, . Adsurgo. LLC. Andrew . Karl, . Adsurgo. LLC. Richard Burdick, Elion Labs. Outline. 2. Introduction. Current. FDA Thinking/Approach. Demonstration:. . Statistical Equivalence using Sample Size and Variance Adjustment Method.