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    Drug Development Team

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    vipinkv99
    The document outlines the different teams involved in drug development from discovery to marketing. It describes 5 key teams: 1) the drug discovery team which identifies lead compounds; 2) the manufacturing/formulation team which develops the dosage form; 3) the preclinical team which conducts animal studies to generate safety data for regulatory approval; 4) the clinical team which runs human trials to generate additional safety data for approval; and 5) the regulatory and marketing teams which handle regulatory filings and market strategies. Each team plays an important specialized role in moving a potential drug through the development process.

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    Drug Development Team

    Uploaded by

    vipinkv99
    578 views2 pages
    The document outlines the different teams involved in drug development from discovery to marketing. It describes 5 key teams: 1) the drug discovery team which identifies lead compounds; 2) the manufacturing/formulation team which develops the dosage form; 3) the preclinical team which conducts animal studies to generate safety data for regulatory approval; 4) the clinical team which runs human trials to generate additional safety data for approval; and 5) the regulatory and marketing teams which handle regulatory filings and market strategies. Each team plays an important specialized role in moving a potential drug through the development process.

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    Drug development team

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    The document outlines the different teams involved in drug development from discovery to marketing. It describes 5 key teams: 1) the drug discovery team which identifies lead compounds; 2) the manufacturing/formulation team which develops the dosage form; 3) the preclinical team which conducts animal studies to generate safety data for regulatory approval; 4) the clinical team which runs human trials to generate additional safety data for approval; and 5) the regulatory and marketing teams which handle regulatory filings and market strategies. Each team plays an important specialized role in moving a potential drug through the development process.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    578 views2 pages

    Drug Development Team

    Uploaded by

    vipinkv99
    The document outlines the different teams involved in drug development from discovery to marketing. It describes 5 key teams: 1) the drug discovery team which identifies lead compounds; 2) the manufacturing/formulation team which develops the dosage form; 3) the preclinical team which conducts animal studies to generate safety data for regulatory approval; 4) the clinical team which runs human trials to generate additional safety data for approval; and 5) the regulatory and marketing teams which handle regulatory filings and market strategies. Each team plays an important specialized role in moving a potential drug through the development process.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    Drug Development Team

    These are the team or group of research associates that are involved in
    the development of a drug product. The areas in which they are
    associated involves from lead drug molecule discovery to marketing of
    drug product

    The drug development team is classified based on their function as


    follows:

    1. Drug discovery project team:


    2. Manufacturing Team (Formulation Development team)
    2. Preclinical drug development project team:
    3. Clinical drug development project team:
    4. Drug Regulatory affairs Team
    5. Marketing team (post-marketing and pre-marketing):

    1. Drug discovery project team:

    The primary responsibility of this group is to identify lead drug


    compounds. They include research people such as synthetic chemists,
    therapeutic disease specialists, pharmacologists or biologists etc. who
    have knowledge regarding cardiovascular, CNS, cancer, infectious
    diseases, metabolic diseases etc. Once a lead drug molecule has been
    identified, the discovery further proceeds further with bioanalytical
    chemists, pharmacokinetics, and toxicology experts etc.

    2. Manufacturing Team (Formulation Development team):

    This team consist of formulation scientists who develop the dosage


    form. They concurrently work with various other teams, during
    nonclinical and clinical drug development team. Their function includes
    preformulation studies, dosage form development, stability studies,
    pilot plant and scale-up process, validation, regulatory documentation,
    packaging, and labeling requirement according to GLP or GMP
    guidelines.
    3. Preclinical drug development project team:

    The responsibility of this group is to establish the preclinical


    development of a lead drug molecule. These include a project team
    leader and coordinator, QA professionals, clinical trial team, analytical
    chemists, manufacturing and marketing analysts. One of the final
    responsibilities of the preclinical drug development project team is to
    conduct animal studies and generate pharmacological, toxicological,
    safety data and then prepare an IND and to the FDA or other regulatory
    agencies.

    As the development of the drug candidate moves into the clinic, the
    preclinical project team becomes a clinical project team.

    4. Clinical drug development project team:

    After the IND is submitted the project team is again expanded to include
    physicians, clinical research associates, drug product production, QA,
    statisticians, clinical pharmacokinetics, regulatory team medical
    monitors, marketing team. They conduct clinical studies in humans
    and generate pharmacological, toxicological, safety data required for
    approval process. The study in conducted in various phases like Phase
    I, II, III etc.

    5. Drug Regulatory affairs Team

    They take care of regulatory requirements with regulatory bodies. They


    file IND, NDA, ANDA etc

    4. Marketing team (post-marketing and pre-marketing):

    This team looks for market potential of drug and design for better sale
    strategies. Further, Phase IV studies (Post marketing Surveillance) are
    undertaken after marketing where new indications, new ADR, long-term
    safety are monitored.

    *************************[email protected]*************************

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