Hongene Biotech Corporation’s Post

📜 Quick digest on FDA Final Guidance for Industry: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics. This recently published guidance provides recommendations for certain evaluations to assist the industry in the development of oligonucleotide therapeutics, including: 1️⃣ characterizing the potential for QTc interval prolongation, 2️⃣ performing immunogenicity risk assessment, 3️⃣ characterizing the impact of hepatic and renal impairment, and 4️⃣ assessing the potential for drug-drug interactions. This snapshot highlights key items from the guidance, providing a useful way to help experts navigate through. Resource from: FDA Reference: https://lnkd.in/ehRJHpYq #RNA #RNAtherapy #RNAtherapeutics #oligonucleotides #oligonucleotidetherapeutic

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