A case‐study of model‐informed drug development of a novel PCSK9 anti sense oligonucleotide. Part 1:...
A case‐study of model‐informed drug development of a novel PCSK9 anti sense oligonucleotide. Part 1: First time in man to phase II
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Publisher
United States: John Wiley & Sons, Inc
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Language
English
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Publisher
United States: John Wiley & Sons, Inc
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Here, we show model‐informed drug development (MIDD) of a novel antisense oligonucleotide, targeting PCSK9 for treatment of hypocholesteremia. The case study exemplifies use of MIDD to analyze emerging data from an ongoing first‐in‐human study, utility of the US Food and Drug Administration MIDD pilot program to accelerate timelines, innovative use...
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A case‐study of model‐informed drug development of a novel PCSK9 anti sense oligonucleotide. Part 1: First time in man to phase II
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TN_cdi_proquest_miscellaneous_2716525747
Permalink
https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_proquest_miscellaneous_2716525747
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ISSN
2163-8306
E-ISSN
2163-8306
DOI
10.1002/psp4.12866
