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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
April 02, 2021
A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality.
October 02, 2019
Using the central limit theorem concerning the distribution of means allows one to justify the assumption of the normal distribution.
October 02, 2018
This article applies the basics of stability, performance, and capability to modern process performance and capability indices.
May 02, 2018
This article looks at a simple structured approach to assigning variance contributions and to assuring that the analytical procedure is fit for purpose.
October 02, 2017
Is there a difference between a specification and a standard?
June 08, 2017
A case study presents important lessons for using average and individual results, as well as user requirements, when qualifying a laboratory refrigerator.
June 02, 2017
This column presents a data case study of a laboratory refrigerator and its qualification performance over five days, with important lessons for using average and individual results, as well as user requirements.
June 02, 2016
Do you have acceptable control of your instruments and analytical procedures?
February 02, 2016
Performing a measurement uncertainty calculation is often seen as problematic.
July 02, 2015
Statistical procedures give statistical answers not analytical judgement.