Update on Therapeutic Protein-Drug Interaction: Information in Labeling.

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  • Additional Information
    • Source:
      Publisher: Country of Publication: Switzerland NLM ID: 7606849 Publication Model: Print Cited Medium: Internet ISSN: 1179-1926 (Electronic) Linking ISSN: 03125963 NLM ISO Abbreviation: Clin Pharmacokinet Subsets: MEDLINE
    • Publication Information:
      Publication: [Switzerland] : Adis, part of Springer Science+Business Media
      Original Publication: New York, ADIS Press.
    • Subject Terms:
      Cytokines/*pharmacokinetics ; Drug Interactions/*physiology ; Drug Labeling/*statistics & numerical data ; Peptides/*pharmacokinetics; Animals ; Clinical Trials as Topic ; Cross-Over Studies ; Cytokines/therapeutic use ; Humans ; Models, Animal ; Peptides/therapeutic use ; Pharmaceutical Preparations/standards ; United States/epidemiology ; United States Food and Drug Administration/organization & administration ; United States Food and Drug Administration/standards
    • Abstract:
      This review evaluated the significance of therapeutic protein (TP)-drug interactions and the current practices for assessing the interaction potential. We reviewed US FDA labels of approved TPs with drug-drug interaction (DDI) assessment. TP-drug interactions have been evaluated from in vitro studies, animal studies, and/or clinical settings. Of the 150 FDA-approved TPs as of May 2019, 49 TP labels contained pharmacokinetic (PK)-related DDI information derived from at least one study method. Our review found that more than half of the clinical PK DDI evaluations showed no interaction, and no dose adjustment has been recommended for any of the rest TPs. The results and trends observed in this review may further enhance and inform risk-based approaches to evaluating the potential for TP-drug interactions.
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    • Accession Number:
      0 (Cytokines)
      0 (Peptides)
      0 (Pharmaceutical Preparations)
    • Publication Date:
      Date Created: 20191005 Date Completed: 20210510 Latest Revision: 20210510
    • Publication Date:
      20240829
    • Accession Number:
      10.1007/s40262-019-00810-z
    • Accession Number:
      31583608