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  • E-Folder - You Can Reach Any Goal In 7 Easy Steps

    There is a difference between people that reach their goals on a regular basis and those that do not. That difference is always some variatio
    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
    n of the following seven steps to success.

    Whether you are a student struggling to succeed in school, or a mega-millionaire figuring
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    out your next big project, the process is the same.



    Become clear about what you want...
    Be specific about what your goal
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    is. It is not enough to say I want to be rich. Instead an attainable goal would say “I want $100,000”. Don’t say I want a better house.
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    Say “I want a 4 bedroom brick ranch on a quarter acre in Tucson”. The clearer you can be about what you want, the easier it is for you to g
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    t there.



    Make it real...
    Write down your goal and put it on the bathroom mirror. A goal not written down is nothing more t
    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
    han a wish. The act of committing it to writing makes it real. Keeping it in front of you every day acts like a nagging friend to hold you
    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
    accountable for achieving it.



    Paint a target...
    Determine when you want your goal to happen. Then include the date in y
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    our goal. None of us ever do things without a deadline. Think back to when you were in school. Would you have done your homework if it wa
    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
    s not going to be collected the next day? Setting target dates motivates us all to do the things necessary to make our goals come true.
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    br>

    What will it take...
    This is where lists are your friend. Make a list of everything you can think of that you will have to do
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    to reach your goal. Revisit the list regularly and add to it as you think of new things. Keep adding to the list until you reach your goal
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    .



    Put some structure into your plan...
    Not every item on the list is as important as the others. Organize your list into
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    the things that are most important and those that are less important. Then arrange them in some order that makes sense to you. Do the firs
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    t things first. For example, you can not paint the house until you buy the paint.



    Start Now...
    Don’t wait for the right
    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
    time. Taking action is the most important step in reaching your goals. As you move toward your goal it will get easier to keep going. Like
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    rolling a stone across a field, the most energy is expended in getting it started. Take some action. Just get moving now.



    Be Con
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    sistent...
    Get in the habit of doing something every day. As you mark the items off your list, your momentum will grow. There is so
    .

    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
    mething very magical about moving closer to a goal. So do something every single day that moves you closer to your goals.



    If you be
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    gin to take these steps on a regular basis you will be amazed at how much you accomplish and how easy it really is to reach any goal.


    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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