Is a DoE-based approach superior to OFAT for HPLC robustness assessment under ICH Q14? A practical case study

European Journal of Pharmaceutical Sciences · Published 2026-05-20 · DOI 10.1016/j.ejps.2026.107561

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Authors (5)

Alba Aragón-Navas, Dennis Walter, Melanie Schmidt, Astrid Heck, Benno Ehrl

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Publication details

Year

2026

Citation

Aragón-Navas, A., Walter, D., Schmidt, M., et al. (2026). Is a DoE-based approach superior to OFAT for HPLC robustness assessment under ICH Q14? A practical case study. European Journal of Pharmaceutical Sciences. https://doi.org/10.1016/j.ejps.2026.107561

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