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    AJ Vinzon
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    The document outlines the drug product development process including pre-clinical and clinical trial stages. It also describes the key documents involved in obtaining regulatory approval, including an Investigational New Drug Application to begin human testing, a New Drug Application to seek market approval after Phase III trials, and supplemental applications for labeling changes or generic versions of approved drugs.

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    Drug Product Development

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    The document outlines the drug product development process including pre-clinical and clinical trial stages. It also describes the key documents involved in obtaining regulatory approval, including an Investigational New Drug Application to begin human testing, a New Drug Application to seek market approval after Phase III trials, and supplemental applications for labeling changes or generic versions of approved drugs.

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    7 views8 pages

    Drug Product Development

    Uploaded by

    AJ Vinzon
    The document outlines the drug product development process including pre-clinical and clinical trial stages. It also describes the key documents involved in obtaining regulatory approval, including an Investigational New Drug Application to begin human testing, a New Drug Application to seek market approval after Phase III trials, and supplemental applications for labeling changes or generic versions of approved drugs.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
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    of 8

    Drug Product Development

    Exercise 12

    Invitro Studies Lead


    Compound

    Pre-Clinical
    Stage Animal
    Testing
    Phase I:
    Efficacy,
    Kinetics

    Phase II:
    Efficacy,
    Toxicities

    Phase III:
    Formulation,
    Toxicities
    Phase IV: Post
    Marketing
    Surveilance

    Documents
    Investigational New Drug Application

    (IND)
    Treatment IND
    New Drug Application (NDA)
    Supplemental NDA
    Abbreviated NDA

    Investigational New Drug Application (IND)


    Required before the drug is to be given

    to human subjects
    Assures the safety of the test subjects
    Checks the soundness of the clinical

    protocol

    Treatment IND

    Warrants the use of

    investigational drug in patients


    with no other therapeutic options

    New Drug Application (NDA)

    Applied for after finishing the first three

    phases of clinical trials


    Contains the drug information and the

    labeling and packaging

    Supplemental NDA

    Applicable for when there are

    changes in any parts of the


    original NDA

    Abbreviated NDA

    Used for the application of me-

    too drugs which omits all tests


    except bioavailability tests for
    the drug

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