Application of the Repeated Measures (Split-Plot) Design to the Development of Processes for Drug Substances

Quality Engineering vol. 16 issue 2 - December 2003

Abstract: [This abstract is based on the authors' abstract.]The usefulness of the repeated measures design in developing processes for drug substances is demonstrated in a case study from the chemical and pharmaceutical industry. The repeated measures design is recommended as an alternative to the usual industry practice of comparing only individual conditions within an experimental unit. An important advantage of the design is the abundance of data that is obtained by considering the entire response curve instead of only isolated individual points on the curve.

Keywords: Case study - Chemical and process industries - Measurement system - Split-plot design - Pharmaceutical industry - Process improvement - Repeatability and reproducibility studies (R&R) - Multiresponse experiment

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