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Get Clinical Evaluation of Medical Devices: Principles and Case PDF

By Karen Becker Witkin (auth.), Karen Becker Witkin (eds.)

ISBN-10: 1475727569

ISBN-13: 9781475727562

ISBN-10: 1617370401

ISBN-13: 9781617370403

In scientific evaluate of scientific units Karen Becker Witkin and her uncommon colleagues summarize for the 1st time the most important ideas and methods for use in scientific machine scientific trials, after which display the implementation of those ideas in a revealing sequence of specified, real-world case experiences. construction at the options utilized in scientific trials of prescribed drugs, those hugely skilled participants express the best way to layout and overview scientific trials of clinical units, in addition to how most sensible to gather information that's applicable to the FDA. additionally they clarify whilst, why, and the way scientific learn matches into the improvement and advertising and marketing of recent product ideas and spell out foreign regulatory standards for examine and registration of clinical units. 9 targeted case experiences illustrate the wide variety of analysis designs which have been effectively utilized to many alternative study difficulties and quite a few healing or diagnostic items.

medical assessment of clinical units won't merely play a key function in constructing scientific trials of scientific units as a rigorous technology, but in addition supply modern purely resource of case-study-based functional info on how scientific examine layout rules are top adapted to the profitable review of novel scientific units.




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Probability sample of clusters of persons representing the civilian noninstitutionalized population, with oversampling of blacks and Hispanics. Data are collected by household interview with medical examination and laboratory testing being conducted in a mobile center. Data include medical histories, physician examination, laboratory tests, and nutritional information from 24-h food recall and foodfrequency interviews. Laboratory testing and physical measurements were more extensive than NHANES II.

5. Thompson, W. D. 1994. Statistical analysis of case-control studies. Epidemiol. Rev. 16:33-50. 6. Hochberg, M. , Perlmutter, D. , Medsger, T. , and Wigley, F. M. 1994. The association of augmentation mammoplasty with systemic sclerosis: results from a multicenter case-control study. Abstract presented at 58th Annual Meeting of the American College of Rheumatology, October 23-27, Minneapolis, MN. 40 McTyre and Pottern 7. MacMahon, B. and Pugh, T. F. 1970. Epidemiology Principles and Methods. Little, Brown, Boston.

This is not the preferred methodology, however, because the comparability of data for cases and controls cannot be assured as data for cases and controls were likely collected at different time periods using different methodologies. 3. Sources of Exposure Data in Case-Control Studies One of the advantages of a case-control study is that one or more exposures or factors of interest can be evaluated with respect to the study outcome. For the purposes of this discussion, the exposures of interest are defined as implanted medical devices or related treatmentes).

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Clinical Evaluation of Medical Devices: Principles and Case Studies by Karen Becker Witkin (auth.), Karen Becker Witkin (eds.)


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