Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics; Guidance for Industry; Availability
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Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics," which provides recommendations for the development of oligonucleotide therapeutics. Specifically, this guidance addresses FDA's current thinking regarding clinical pharmacology considerations and recommendations for oligonucleotide therapeutic development programs, including characterizing the potential for QT interval prolongation, performing immunogenicity risk assessment, characterizing the impact of hepatic and renal impairment, and assessing the potential for drug-drug interactions. This guidance finalizes the draft guidance of the same name issued on June 27, 2022.
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