Výsledky vyhledávání - "Suren Bandara"

Setting impurity limits for endogenous substances: Recommendations for a harmonized procedure and an example using fatty acids

Autor: Robert A. Jolly, Suren Bandara, Joel Bercu, Courtney M. Callis, David G. Dolan, Jessica Graham, Diem HaMai, Ester Lovsin Barle, Andrew Maier, Melisa Masuda-Herrera, Chandrika Moudgal, Jillian A. Parker, John Reichard, Reena Sandhu, Ernest S. Fung

Publikováno v: Regulatory toxicology and pharmacology : RTP. 134

Endogenous substances, such as fatty, amino, and nucleic acids, are often purposefully used in parenterally pharmaceuticals, but may be present as impurities. Currently, no consensus guidance exists on setting impurity limits for these substances. Sp

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0a2bcf6e3588100ffbd92c6f51b5bf1c
https://pubmed.ncbi.nlm.nih.gov/35964842

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The utility of hERG channel inhibition data in the derivation of occupational exposure limits

Autor: Jillian A. Parker, Ernest S. Fung, Alejandra Trejo-Martin, Lisa Liang, Katherine Gibbs, Suren Bandara, Stephanie Chen, Reena Sandhu, Joel Bercu, Andrew Maier

Publikováno v: Regulatory toxicology and pharmacology : RTP. 134

Inhibition of the human ether-à-go-go (hERG) channel may lead to QT prolongation and fatal arrhythmia. While pharmaceutical drug candidates that exhibit potent hERG channel inhibition often fail early in development, many drugs with both cardiac and

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::52be179d00f4f514f91a63cd310ba0f0
https://pubmed.ncbi.nlm.nih.gov/35817210

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