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    _____________________________________(10,10)


    Nirvana
    S
    T
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    E
    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
    (5,5)
    S
    S_____________________________________


    (0,0) -------------->>> (10,0)


    MONEY


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

    Examples of combination products may in
    Wealth chart, above, measures your real wealth. Your real wealth is a combination of money and happiness or money and stress. (Incidentally, a similar ch
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    art can be made of Money vs. Time, where wealth is measured by the combination of money and free time, but that’s a different subject.)

    I look at happiness
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    and stress as direct opposites – the more happiness, the less stress and, conversely, the more stress, the less happiness.

    The horizontal X-axis, going fr
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    om left to right, rates the money you have. The lower left hand corner is “no money”; the middle is a “5” – solid middle class; and the right-hand corner i
    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
    s a ‘10’, meaning “lots and lots of money.”

    The vertical Y-axis measures your happiness or stress. The higher you go, the more happiness and less stress.
    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
    The lower-left hand corner means you have no money and high stress or no money and no happiness. The right hand side of the chart means more-than-average
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    money. The top half of the chart is more-than-average happiness (less-than-average stress.)

    Where are you on this chart? The bottom left quadrant houses
    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
    people with insufficient money and too much stress. Many of us are in this condition. There’s not as much money as there is month and the last week of eac
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    h month may be fraught with tension.

    When you get above the mid-line, you have reduced stress. People with little money and no stress are in the upper lef
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    t quadrant – not a bad place to be, content with their financial condition. From time to time they may run short of money, but they handle it with a smile,
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    without panic, without stress. They lead happy lives.

    The basis for a surprising number of movie and TV comedies is the battle between the upper left qua
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    drant people and the lower right quadrant people: poor and happy versus rich and stressed.

    The bottom right is for the Elvis Presleys and Marilyn Monroes
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    f the world. Money doesn’t solve their problems and may add to them. They have all the money they need, but can’t truly enjoy their status. At the least,
    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
    they worry all the time. I knew a very wealthy man who always worried that he didn’t have enough money. When I asked him how much would be enough, he sai
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    d, “all of it.”

    Of course, each quadrant is large and many of us are closer to the center than to the corners:
    - just enough money and not much stress
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

    - just enough money and more stress than we want
    - almost enough money and not much stress
    - almost enough money and a bit too much stress
    .

    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
    r>

    And many of us bounce from quadrant to quadrant. For three and a half weeks, we’re happy and then the bills come due.

    The measure of wealth is that ma
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    gic combination of enough financial well-being and enough emotional well-being.

    Where do you rate? How often does it change? What can you do to change it


    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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