Concepedia

Analytical Lifecycle Management (ALM) and Analytical Quality by Design (AQbD) for analytical procedure development of related substances in tenofovir alafenamide fumarate tablets

Jian-Hao Teng, Chunmei Zhu, Jinyuan Lyu, Linyu Pan, Meng Zhang, Fuli Zhang, Haoxiang Wu

Journal of Pharmaceutical and Biomedical Analysis · 2021 · 18 citations · 14 references

DOI

Concepts

References

14

Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)

Isa Martins Fukuda, Camila Francini Fidelis Pinto, Camila dos Santos Moreira et al. · Brazilian Journal of Pharmaceutical Sciences · 2018 · 387 citations · Full text

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Use of ultra-performance liquid chromatography in pharmaceutical development

Stephen Wren, Pierre Tchelitcheff · Journal of Chromatography A · 2006 · 237 citations

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FDA Approval of Remdesivir — A Step in the Right Direction

Daniel B. Rubin, Kirk M. Chan‐Tack, John Farley et al. · New England Journal of Medicine · 2020 · 224 citations · Full text

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Development and Optimization of Liquid Chromatography Analytical Methods by Using AQbD Principles: Overview and Recent Advances

Tim Tome, Nina Žigart, Zdenko Časar et al. · Organic Process Research & Development · 2019 · 211 citations · Full text

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Selectivity in reversed-phase separations

Uwe D. Neue, John E. O’Gara, Alberto Méndez · Journal of Chromatography A · 2006 · 123 citations

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