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  • Your Space - Motivation: Do You Got Game?

    So what's the size of your game? For what in your life do
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    you have a burning passion? What are you hungry for?

    Ho
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    much passion do you bring to your life? Here are three c
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    tegories, only one of which you want to live in.

    People
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    pproach the things they want in life in one of three ways
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro


    I want to want to

    These people give some kind o
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    intellectual assent to the notion of change. It looks li
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    ke "Yeah, that's something I should do" or "It sure would
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    be nice if."

    Don't count on any change here.

    I want
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    o

    This is a little bit better than I want to want to
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    but not much. Here you will find a lot of lip service ab
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ut change.

    I must

    Things happen here.

    Actions a
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    e taken, and progress is made.

    The state of "I must" mea
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    s that change must happen, no matter what.

    To what in yo
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ur life can you bring that same kind of passionate commit
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    ent? How big is your game? How big would you like it to b
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ? Could it be your marriage, your family, your job, even
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    hobby?

    Next question. What are you waiting for?

    The an
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    wer is, nothing of any significance.

    Just one more quest
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    on — what's stopping you?

    The answer is usually yourself


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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