Reliability evaluation of nonlinear design space in pharmaceutical product development

Yoshihiro Hayashi1, Shingo Kikuchi, Yoshinori Onuki

  • 1Department of Pharmaceutics, Hoshi University, 2-4-41 Ebara, Shinagawa-ku, Tokyo 142-8501, Japan.

Summary

This study explored the formulation design space for indomethacin tablets using a nonlinear response surface method (RSM-S). A resampling method assessed the reliability of the estimated design space, revealing decreased reliability near experimental edges.

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