Current Industry Best Practice on in-use Stability and Compatibility Studies for Biological Products

Evaluating the in-use stability of a biological product including its compatibility with administration components allows to define handling instructions and potential hold times that retain product quality during dose preparation and administration. The intended drug product usage may involve the d...

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Veröffentlicht in:	Journal of pharmaceutical sciences 2023-09, Vol.112 (9), p.2332-2346
Hauptverfasser:	Blümel, Markus, Liu, Jing, de Jong, Isabella, Weiser, Sarah, Fast, Jonas, Litowski, Jennifer, Shuman, Melissa, Mehta, Shyam B., Amery, Leanne, Tan, David Cheng Thiam, Jia, Feng, Shekhawat, Dushyant, Dagallier, Camille, Emamzadeh, Mina, Medina, Annette, Santos, Camilla, Gasser, Florian, Urban, Christian
Format:	Artikel
Sprache:	eng
Schlagworte:	Analytical chemistry Polymeric drug delivery system(s) Protein delivery Regulatory science
Online-Zugang:	Volltext
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