Purity profile for Stimufend<sup>®</sup> and Neulasta<sup>®</sup>.

<p>The plot shows overlaid size exclusion–HPLC profiles of US-licensed Neulasta<sup>®</sup>, EU-approved Neulasta<sup>®</sup>, and MSB11455 batches, and a similar profile for Stimufend<sup>®</sup> compared to Neulasta<sup>®</sup>.</p>

محفوظ في:

التفاصيل البيبلوغرافية
المؤلف الرئيسي:	Alison Sykes (19942577) (author)
مؤلفون آخرون:	Louise Ingram (19942580) (author), Ulrich Kronthaler (19942583) (author), Laurent Chevalet (19942586) (author)
منشور في:	2024
الموضوعات:	Biochemistry Medicine Pharmacology Biotechnology Cancer Science Policy Infectious Diseases unmet medical need patients acutely exposed measured quality attributes critical quality attributes clinically significant differences art orthogonal techniques stimulating factor biologic higher order structure designed using state reference product neulasta xlink "> pegfilgrastim xlink "> primary structure compared using biologic therapy product variants product profile variability ). two products scientific considerations risk ranking related impurities quantitative parameters pegfilgrastim ): myelosuppressive doses marketing approval increase survival impurity profiles functional biosimilarity febrile neutropenia drug administration descriptive assessment defined range cancer drugs biological properties biological activity
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