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  • SA Ind Gantt Charts Large Molecule

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    Uzy
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    The document provides a full timeline from weeks 0-27 for preclinical investigational new drug (IND)-enabling activities, including large molecule development and validation, immunogenicity development and validation, toxicology range-finding studies in rats and non-human primates (NHP), 28-day toxicology studies in rats and NHPs, and tissue cross-reactivity work. The timeline is meant to be optimized for speed but should be customized based on a project's specific data and intended use.

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    SA-ind-gantt-charts-large-molecule

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    The document provides a full timeline from weeks 0-27 for preclinical investigational new drug (IND)-enabling activities, including large molecule development and validation, immunogenicity development and validation, toxicology range-finding studies in rats and non-human primates (NHP), 28-day toxicology studies in rats and NHPs, and tissue cross-reactivity work. The timeline is meant to be optimized for speed but should be customized based on a project's specific data and intended use.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    62 views1 page

    SA Ind Gantt Charts Large Molecule

    Uploaded by

    Uzy
    The document provides a full timeline from weeks 0-27 for preclinical investigational new drug (IND)-enabling activities, including large molecule development and validation, immunogenicity development and validation, toxicology range-finding studies in rats and non-human primates (NHP), 28-day toxicology studies in rats and NHPs, and tissue cross-reactivity work. The timeline is meant to be optimized for speed but should be customized based on a project's specific data and intended use.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 1

    Full Timeline (Weeks 0-27)

    Prep 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27

    Large Development
    and validation

    Molecule Development, validation,


    and bioanalysis

    IND Immunogenicity:

    Timeline
    development and validation

    Reporting and audit

    Given the increasing pressures,


    understanding how and when to
    plan a preclinical investigational
    Toxicology
    new drug (IND)-enabling program is
    an integral part of meeting specific
    Range-finding in rat and NHP
    milestones necessary for timely and
    efficient IND submission. Please
    note the Gantt Chart is only an 28-day study in rat and NHP
    estimate optimized for speed and
    should be customized based on
    your lead optimization data, specific Tissue cross-reactivity
    modality, therapeutic area, and
    intended clinical use.
    Reporting and audit
    + Learn more

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