An NMR-Based Similarity Metric for Higher Order Structure Quality Assessment Among U.S. Marketed Insulin Therapeutics

Protein or peptide higher order structure (HOS) is a quality attribute that could affect therapeutic efficacy and safety. Where appropriate, the HOS similarity between a proposed follow-on product and the reference listed drug should be demonstrated during regulatory assessment. Establishing quantit...

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Veröffentlicht in:	Journal of pharmaceutical sciences 2020-04, Vol.109 (4), p.1519-1528
Hauptverfasser:	Wang, Deyun, Park, Junyong, Patil, Sharadrao M., Smith, Cameron J., Leazer, John L., Keire, David A., Chen, Kang
Format:	Artikel
Sprache:	eng
Schlagworte:	dialysis higher order structure (HOS) insulin glargine insulin human insulin lispro Mahalanobis distance mass balance principal component analysis (PCA)
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