Articles by Chris Burgess - Pharmaceutical Technology

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Articles by Chris Burgess

Using the Guard Band to Determine a Risk-Based Specification

Calculate a risk-based guard band associated with reportable values derived from knowledge of the analytical procedure capability.
Oct 2, 2014

A risk-based guard band surrounds a specification limit and is derived from the uncertainty of the reportable value of the analytical procedure, which includes the uncertainty in the reference standard. The author discusses requirements for generating a reportable value and calculating the associated measurement uncertainty.

Is a Sample Size of n=6 a Magic Number?

Statistical analysis shows how much testing is needed to deliver a reliable estimate result.
Jun 2, 2014

Statistical analysis shows how much testing is needed to deliver a reliable estimate result.

Calibration of instruments: Is Your UV Spectrometer Accurate Enough

This article takes a statistical look at the calibration requirements for a UV spectrometer.
Jan 2, 2014

This article takes a statistical look at the calibration requirements for a UV spectrometer.

The Basics of Measurement Uncertainty in Pharma Analysis

How good is a reportable value?
Sep 2, 2013

How good is a reportable value?

Evaluating Risk-Based Specifications for Pharmaceuticals

The author discusses the purpose of analysis and testing and the implications for specifications and their underlying statistical distribution.
Jul 2, 2013

The author discusses the purpose of analysis and testing and the implications for specifications and their underlying statistical distribution.

Rounding Results for Comparison with Specification

The mysteries of rounding are exposed.
Apr 2, 2013

The mysteries of rounding are exposed; strict, unbiased rounding can be applied.

Calculating the Reportable Result from Retest Data

Two methods to evaluate retest data following out-of-specification results.
Feb 2, 2013

Two methods to evaluate retest data following out-of-specification results.

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