The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods. This article contain bonus online material. This paper has been constructed to ...
The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts. Analytical quality ...
Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...
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