Establishment of an equivalence acceptance criterion for accelerated stability studies.

@article{Burdick2013EstablishmentOA,
  title={Establishment of an equivalence acceptance criterion for accelerated stability studies.},
  author={Richard K. Burdick and Leslie Sidor},
  journal={Journal of biopharmaceutical statistics},
  year={2013},
  volume={23 4},
  pages={
          730-43
        }
}
In this article, the use of statistical equivalence testing for providing evidence of process comparability in an accelerated stability study is advocated over the use of a test of differences. The objective of such a study is to demonstrate comparability by showing that the stability profiles under nonrecommended storage conditions of two processes are equivalent. Because it is difficult at accelerated conditions to find a direct link to product specifications, and hence product safety and… CONTINUE READING
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Determination of acceptance criteria and sample sizes for accelerated stability comparability studies for biologics.

  • Biologicals : journal of the International Association of Biological Standardization
  • 2017
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