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    Duopa®

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    thabitjuma89

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    © All Rights Reserved
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    Duopa®

    Uploaded by

    thabitjuma89
    21 views8 pages

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    Duopa® PPT

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    21 views8 pages

    Duopa®

    Uploaded by

    thabitjuma89

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
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    Duopa®/Duodopa®

    CDET
    Duopa®/Duodopa®
    Duopa®/Duodopa® is an intestinal gel containing Levodopa and
    Carbidopa. It is indicated for patients with advanced Parkinson's
    disease who are responsive to levodopa but experience severe motor
    fluctuations and excessive involuntary movements, especially when
    other combinations of Parkinson's drugs have not yielded satisfactory
    results (AbbVie Limited, 2022).
    Duopa®/Duodopa® consist of three
    components

    Diagram 1. Components of Duopa®/Duodopa® (Parkison’s Fundation)


    AbbVie Position

    • AbbVie’s Duopa®/Duodopa® is approved by USFDA in 2015 as


    combination product with use of CADD®-legacy 1400 pump and PEG-
    J/NJ tube.
    • AbbVie Inc., one of the ‘big pharm’ industries, undoubtedly had an
    established drug cGMP operating system in place even before
    commencing the production of Duopa®/Duodopa®. From product
    information leaflet it was indicated Pump is manufactured by Smiths
    Medical ASD, Inc., which is established to manufacture medical devices.
    • To comply with USFDA requirements (21 CFR part 4), the manufacturer
    must demonstrate compliance with both the drug cGMPs and the
    device QS regulation.
    • This can be achieved by using the drug CGMP-based streamlined
    approach in accordance with 21 CFR 4.4(b)(1).
    Design inputs and outputs
    Design Input/User Specifications Design Output
    Required minimum/maximum dose delivery for drug Electronic programmable systems, including software
    designed to ensure the repeatability, reliability and
    performance of these systems accordingly

    Drug viscosity and desired/required delivery rate Drawing/specification for pump, cassette tube, connector,
    stomach tube (PEG-J/NJ) etc.
    Expected use condition (e.g., expected user Content and reading level for the Duopa’s labeling
    experience/education level)
    Maximum allowable temperature during transportation, Packaging/labeling specifications for each constituent
    handling, and storage for each constituent

    No degradation of the drug, cassette tube, connector, or Specifications for drug-contacting tube materials
    stomach tube (PEG-J/NJ) occurs over the expected use time
    due to contact with one another

    Expected shipping method and appropriate storage Design drawings/specifications for primary and secondary
    conditions for each constituent packaging, labeling for acceptable storage conditions
    Risk analysis and mitigation
    Risk Mitigation
    Pump failure during use or the delivery of an incorrect Design verification testing on pump and software,
    drug dose labeling (instructions for use), purchasing controls
    over pump component manufacturer(s)

    Gastrointestinal and Gastrointestinal Procedure- Establishing standard procedures in the Duopa system
    Related Risk guide for healthcare professionals to observe before
    inserting the tubes, while inserting the tubes, and
    after inserting the tubes

    Drug degrades during use Design verification testing (bench), clinical testing,
    labeling (instructions for use), purchasing controls
    over cassette tube, connector, and stomach tube
    (PEG-J/NJ suppliers, specifications and other process
    controls
    References
    • AbbVie Limited. (2022). Prescribing Information.
    https://www.abbviepro.com/ie/en/neuroscience/neurology/products/duodopa/prescribing-information.html

    • Parkinson’s Foundation. Duopa | Parkinson’s Foundation. Available at: https://www.parkinson.org/living-with-


    parkinsons/treatment/surgical-treatment-options/duopa (Accessed: 17 October 2023).

    • USFDA. (2017). Guidance for industry and FDA staff: Current Good Manufacturing Practice Requirements for
    Combination Products. https://www.fda.gov/media/90425/download (Accessed: 17 October 2023).

    • AbbVie Inc. (AbbVie). (2017). Core/EU Risk Management Plan for levodopa.
    https://laegemiddelstyrelsen.dk/upload/rmp/28103637704%2013-03-2017.pdf (Accessed: 17 October 2023).

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