A controlled vocabulary and taxonomy for the submission of quality attributes for therapeutic proteins

Abstract Structured product quality data offer tremendous promise to revolutionize the submission of drug applications. However, the quality attributes for biological products do not have a systematic naming taxonomy, and consequently this limit poses a critical challenge in the development of syste...

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Principais autores: Joel T. Welch (Autor), Steven Kozlowski (Autor), Bazarragchaa Damdinsuren (Autor), Brian A. Roelofs (Autor)
Formato: Livro
Publicado em: SpringerOpen, 2024-08-01T00:00:00Z.
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