Can I read FDA Guidance on Oligonucleotide Therapies on EtoBox?
FDA Guidance on Oligonucleotide Therapies by Hemant Mehta is a document available to read on EtoBox.
What is FDA Guidance on Oligonucleotide Therapies about?
This document provides guidance from the FDA on the clinical pharmacology considerations for the development of oligonucleotide therapeutics. Key recommendations include assessing QTc interval prolongation, immunogenicity risks, and the impact of hepatic and renal impairment on pharmacokinetics and safety. It emphasizes the importance of tailored evaluations due to the unique characteristics of oligonucleotide drugs and encourages communication with the FDA during the development process.
- Author
- Hemant Mehta
- Language
- EN