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

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

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...

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Veröffentlicht in:Clinical pharmacology and therapeutics 2023-04, Vol.113 (4), p.816-821
Hauptverfasser: Haarst, Aernout, Smith, Stephen, Garvin, Clare, Benrimoh, Natacha, Paglialunga, Sabina
Format: Artikel
Sprache:eng
Schlagworte:
Cytochrome P-450 CYP3A
Cytochrome P-450 CYP3A Inducers - pharmacokinetics
Drug Interactions
Drugs, Investigational
Humans
Rifampin - pharmacokinetics
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Zusammenfassung: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.
ISSN:0009-9236
1532-6535
DOI:10.1002/cpt.2652