Articles by Terry Orchard - BioPharm International

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Articles by Terry Orchard

Specification Setting: Setting Acceptance Criteria from Statistics of the Data

Nov 1, 2006

This article shows how Probabilistic Tolerance Intervals of the form, "We are 99% confident that 99% of the measurements will fall within the calculated tolerance limits" can be used to set acceptance limits using production data that are approximately Normally distributed. If the production measurements are concentrations of residual compounds that are present in very low concentrations, it may be appropriate to set acceptance limits by fitting a Poisson or an Exponential Distribution.

A Signal-to-Noise Ratio is No Subsitute for a Brain

The relevance of control charts to signal-to-noise ratio
Mar 1, 2006

Signal-to-noise ratios are useful in robust engineering to design products and processes that consistently deliver on target.

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