A case‐study of model‐informed drug development of a novel PCSK9 anti sense oligonucleotide. Part 1: First time in man to phase II

A case‐study of model‐informed drug development of a novel PCSK9 anti sense oligonucleotide. Part 1: First time in man to phase II

Abstract 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...

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Bibliographic Details
Main Authors: Jane Knöchel, Catarina Nilsson, Björn Carlsson, Linda Wernevik, Alexis Hofherr, Peter Gennemark, Rasmus Jansson‐Löfmark, Rikard Isaksson, Tina Rydén‐Bergsten, Bengt Hamrén, Dinko Rekić
Format: Article
Language:English
Published: Wiley 2022-12-01
Series:CPT: Pharmacometrics & Systems Pharmacology
Online Access:https://doi.org/10.1002/psp4.12866

Internet

https://doi.org/10.1002/psp4.12866

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