Considerations and recommendations for assessment of plasma protein binding and drug-drug interactions for siRNA therapeutics

At the time of writing, although siRNA therapeutics are approved for human use, no official regulatory guidance specific to this modality is available. In the absence of guidance, preclinical development for siRNA followed a hybrid of the small molecule and biologics guidance documents. However, siR...

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Veröffentlicht in:	Nucleic acids research 2022-06, Vol.50 (11), p.6020-6037
Hauptverfasser:	Humphreys, Sara C, Davis, John A, Iqbal, Sajida, Kamel, Amin, Kulmatycki, Kenneth, Lao, Yanbin, Liu, Xiumin, Rodgers, John, Snoeys, Jan, Vigil, Adam, Weng, Yan, Wiethoff, Christopher M, Wittwer, Matthias B
Format:	Artikel
Sprache:	eng
Schlagworte:	Biological Products Blood Proteins - chemistry Critical Reviews and s Decision Trees Drug Interactions Humans Protein Binding RNA, Small Interfering - chemistry RNA, Small Interfering - genetics RNA, Small Interfering - pharmacology
Online-Zugang:	Volltext
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