Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics; Draft Guidance for Industry; Availability
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics." This draft guidance describes FDA's recommendations regarding clinical pharmacology considerations during the development of oligonucleotide therapeutics, including characterizing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. The intent of this guidance is to assist industry in the conduct of these studies.
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