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Review
. 2023 Apr;113(4):816-821.
doi: 10.1002/cpt.2652. Epub 2022 Jun 22.

Rifampin Drug-Drug-Interaction Studies: Reflections on the Nitrosamine Impurities Issue

Aernout van Haarst  1 , Stephen Smith  2 , Clare Garvin  2 , Natacha Benrimoh  3 , Sabina Paglialunga  4
Affiliations
Review

Rifampin Drug-Drug-Interaction Studies: Reflections on the Nitrosamine Impurities Issue

Aernout van Haarst et al. Clin Pharmacol Ther. 2023 Apr.

Abstract

Clinical development of new drugs may require dedicated drug-drug interaction (DDI) studies, such as to evaluate the effect of cytochrome P450 3A induction on the pharmacokinetics of investigational drugs. However, as a result of N-nitrosamine impurity findings in marketed rifampin formulations, the application of rifampin in DDI studies has been halted. This mini-review considers the root cause and impact of the nitrosamine impurity as well as alternative options for the continued conduct of DDIs.

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References

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