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Clinical Data to Support Qualification: Cross-Sectional Surveys and Natural History Studies

Clinical Data to Support Qualification: Cross-Sectional Surveys and Natural History Studies. P. K. Tandon, Ph.D. Clinical Science Officer Genzyme, a Sanofi Company. Clinical data to support biomarker/endpoint qualification: most difficult to obtain.

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373 views • 22 slides

Sensitivity and Uncertainty

Sensitivity and Uncertainty. Sources of Uncertainty. There are multiple sources of uncertainty associated with the present effort Uncertainty in the simplifying assumptions used in the analysis (e.g. hydrostatic assumption, cross-sectional averaging, etc.)

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231 views • 5 slides

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Sufficient observations - PowerPoint PPT Presentation

Clinical Data to Support Qualification: Cross-Sectional Surveys and Natural History Studies

Sensitivity and Uncertainty