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    At some point in your life have you ever dreamed of being somebody special, somebody big? Have you ever fantasized about being the one who scores the winning goal? Do you remember your childhood dreams of becoming the homecoming queen? How many times have you
    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
    fantasized of being rich, or successful, or happy in your relationships?

    We often dream and have great aspirations about our lives and our future. Unfortunately, our dreams remain just that – dreams. And our aspirations easily collect dust in our attic. Rem
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    mber the days when you used to say to Mom or Dad "I'm going to be a professional sportsman when I'm older"? Do you remember the comments? How many times did someone say to you "Stop dreaming and start being more realistic".

    This is a sad turn of events in ou
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    r life. Instead of experiencing exciting adventures in self actualization, we get caught up in the humdrum of living from day-to-day just barely existing. We totally forget what our dreams and goals in life are.

    Wouldn't life be so much better, if only we le
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    rned to aim higher?

    The most common problem to setting goals is the word impossible. Most people get hung up thinking I can't do this. It's too hard. It's too impossible. No one can do this.

    However, if everyone thought that, there would be no inventions, n
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    innovations, and no breakthroughs in human accomplishment. There would be no Richard Branson's, Donald Trump's or John F Kennedy's of the world.

    Remember that scientists once argued that the world was flat. When the telephone first came out people said it w
    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
    as an impractical form of communication. Where would we be if it wasn't for the inventors and explorers of this world who didn't accept impossible as an answer?

    On the other hand, some people suffer from dreaming totally outrageous dreams and not acting on t
    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
    em. Or if they do act upon them they do it without proper planning and with no thought process behind their actions to follow. The result? Broken dreams, and tattered aspirations.

    If you limit yourself with self-doubt, and self-limiting assumptions, you will
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    never be able to break past what you deem impossible. If you reach too far out into the sky without working towards your goal, you will find yourself clinging on to the impossible dream. You cannot achieve the dream without finding out the reasons why people
    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
    say it is impossible. Once you understand the reasons, you can work to find a solution to your problems and move on to succeed in life.

    Try this exercise. Take a piece of paper and write down some goals in your life. Under one header, list down things ‘you k
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ow you can do’. Under another header, write the things ‘you might be able to do.’ And under one more, list the things that that are impossible for you to do.’

    Now look at all of the headers. Strive every day to accomplish the goals that are under the header
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ‘you know you can do’. Tick them when you are able to accomplish them. As you slowly are able to check all of your goals under that heading, try accomplishing the goals under the other header-the one that reads ‘you might be able to do.’

    As time goes on you
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ill see yourself starting to achieve your goals. As you iterate through this process, you will find out that the goals you thought were impossible suddenly become possible after all.

    You see, the technique here is not to limit your imagination. It is to aim
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    high, and start working towards that goal little by little. Set yourself daily/weekly tasks of what you need to achieve. Don’t get disheartened when it doesn't quite go to plan. Look back at your experiences and learn from them. After all isn't that what a mi
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    take is, an opportunity to learn?

    You don’t have to be one of those who just dream towards a goal. You can be one of the ones who turn their dreams into a reality. What do "they" have that you do not have?

    Think about it, if you told someone a hundred years
    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
    ago that it was possible for man to be on the moon, they would laugh at you. If you had told them that you could send mail from here to the other side of the world in a few seconds, they would say you were out of your mind. But, through sheer desire and perse
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    verance, these impossible dreams are now realities.

    Thomas Edison once said that genius is 1% inspiration and 99% perspiration. Nothing could be true. For you to accomplish your dreams, you have to work hard and discipline yourself. But take note that that 1
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    has to be a think-big dream, and not some easily accomplished one.

    Set your dreams and goals high. Commit to yourself that you will do what ever it takes to become a success. Choose to live your life on your terms, not somebody else’s.

    Remember the saying,
    .

    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
    “No pain, no gain”? That is as true as it can be.

    So dream on! Don’t get caught up with your perceived limitations. Think big and work hard to attain those dreams. As you step up the ladder of success, you will find out that what seemed to be the impossible
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    is not impossible at all. With a little planning, hard work and determination, anything you dream of is possible.

    Remember, impossible is just a word. Success is a combination of action, experience, learning and passion. Live your life to fulfill your dreams


    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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