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

• Main Authors: Jane Knöchel (Author), Catarina Nilsson (Author), Björn Carlsson (Author), Linda Wernevik (Author), Alexis Hofherr (Author), Peter Gennemark (Author), Rasmus Jansson‐Löfmark (Author), Rikard Isaksson (Author), Tina Rydén‐Bergsten (Author), Bengt Hamrén (Author), Dinko Rekić (Author)
• Format: Book
• Published: Wiley, 2022-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...