Articles by Chris Burgess - Pharmaceutical Technology

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Articles by Chris Burgess

Chris Burgess


Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, Rose Rae, The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

Articles
Using the Guard Band to Determine a Risk-Based Specification
October 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?
June 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
January 2, 2014

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

The Basics of Measurement Uncertainty in Pharma Analysis
September 2, 2013

How good is a reportable value?

Evaluating Risk-Based Specifications for Pharmaceuticals
July 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
April 2, 2013

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

Calculating the Reportable Result from Retest Data
February 2, 2013

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

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