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    What if, from this minute forward, you began to see every difficulty in life as a challenge to be overco
    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
    me rather than a problem, interruption, irritation, or a hassle to be gotten rid of? It’s never hard to
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    spot the problems in life and it’s pretty easy to go around exposing them for the world to see. It doesn
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ’t take much effort to complain and fret about how difficult a particular problem is making your life.

    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    However, true greatness requires an entirely different kind of person, one who is able to recognize the
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    hallenges within the difficulties and immediately starts looking for a creative and innovative solution
    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
    to the issues at hand.

    When you are able to see the negatives of life as a challenge, you will be more
    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
    tenacious in looking and uncovering all kinds of possible solutions because you will be able to see the
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    possibilities and opportunities at hand. As you approach the situation more as a puzzle to be solved or
    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
    something to be conquered, you are much more apt to find the answers you are looking for because you are
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    thinking in a more positive direction. (Don’t we all know that negativity can be a real blocker to creat
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ivity!)

    Sharing possible solutions with others to capture their opinions, thoughts, perspectives and at
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    titudes is vital, and will be helpful when it comes time to implement change.

    Opportunities will abound
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    for you in your work when you see things differently than your co-workers. When they see the problem, y
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ou will see the opportunity within the challenge. You will enthusiastically seize the opportunity, becau
    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
    e you have determined to think “challenge” instead of “problem” while your co-workers will often continu
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    e to stick their head in the sand, hoping the problems will solve themselves.

    So what have you got to l
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ose, if you decide to rip the word “problem” right out of your vocabulary, today, and replace it with th
    .

    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
    e word “challenge”? Choose now to take action, and keep on taking action on the challenges in your life,
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    and you will see all the problems disappear.

    ©2005 Professional Development Systems All Rights Reserve


    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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