Improvement of a stability-indicating method by Quality-by-Design versus Quality-by-Testing: a case of a learning process.

@article{Hubert2014ImprovementOA,
  title={Improvement of a stability-indicating method by Quality-by-Design versus Quality-by-Testing: a case of a learning process.},
  author={C{\'e}dric Hubert and Pierre Lebrun and S Houari and Eric Zi{\'e}mons and Eric Rozet and Peter Hubert},
  journal={Journal of pharmaceutical and biomedical analysis},
  year={2014},
  volume={88},
  pages={401-9}
}
The understanding of the method is a major concern when developing a stability-indicating method and even more so when dealing with impurity assays from complex matrices. In the presented case study, a Quality-by-Design approach was applied in order to optimize a routinely used method. An analytical issue occurring at the last stage of a long-term stability study involving unexpected impurities perturbing the monitoring of characterized impurities needed to be resolved. A compliant Quality-by… CONTINUE READING

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