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# Guide on Oligonucleotide Therapeutic Development
- URL: https://www.fdaweb.com/guide-on-oligonucleotide-therapeutic-development/
- Published: 2022-06-24T12:00:00.000Z
- Updated: 2026-09-14T17:50:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152161

FDA has made available a [draft guidance](https://www.fda.gov/media/159414/download?ref=fdaweb.com) entitled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.” The document provides recommendations for certain evaluations including pharmacokinetic, pharmacodynamic, and safety assessments during oligonucleotide therapeutic development, including: (**1**) characterizing the potential for QTc interval prolongation, (**2**) performing immunogenicity risk assessments, (**3**) characterizing the impact of hepatic and renal impairment, and (**4**) assessing the potential for drug-drug interactions. It also discusses the timing of when to conduct these assessments.