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  • Summary - I'm OK, You're Not So Hot: The Root of Prejudice

    When a dream startles us awake, it demands our attention.

    I opened the door to find an attractive Pakistani woman on my doorstep. She asked to
    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
    come in to borrow a cake pan. I let her in and told her to look in the cupboards as I was fixing coffee for my family and preoccupied.

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

    Examples of combination products may in
    nts were visiting for the first time; my sister and her new husband were also there. I was anxious to get the coffee started when the woman ask
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ed if I had a certain type of cake pan. I did not and told her she could go to the store nearby and probably find one. She resisted this idea a
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    d suggested that I could use a pan like that; why don't I buy one?

    I was incensed. In my mind, I had let this woman into my home, offered to l
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    an her what items I had to make her stupid cake and then she had the nerve to suggest I buy the cake pan that she needed. I forced her bodily f
    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
    rom my home.

    In the light of day, this dream (like so many) seems stupid. But someone once advised that in order to unearth the cause of a dre
    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
    m, we must dissect the root of its emotion. I awoke enraged. What was the nature of this extreme reaction?

    I began tentatively to view the exp
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    rience from the woman's perspective. Could it be that she wanted me to have the cake pan so that I might bake a cake for my family? Could it be
    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
    that she wanted to share the joy of what if means to give to others? Was the cake a metaphor for the sweetness in life that I refused to parta
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    e?

    I do not know the Pakistani culture, but I recalled an experience I had with some Armenian friends many years ago. They too offered me cake
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    which I did not eat. Later a friend told me that this was a great insult. They did not show it, so I did not know, but in my righteous refusal
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    of calories, I missed an opportunity for friendship.

    I wonder how often we reject people and cultures because of our limited worldview?

    Many
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ears ago, when my son was a newborn, my husband needed to travel out of state. He didn't want to the two of us to stay at home alone and insist
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    d we join him for the 1500 mile car trip. I was too young to argue and was miserable the whole time. All I wanted was sleep.

    A month later, af
    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
    ter my six-week maternity leave was over and I had returned to work, he bought tickets to Tahiti for my birthday. Flying halfway across the wor
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    d with an infant at home was not my idea of a vacation. I returned exhausted and sick with strep throat.

    For years I harbored anger at his ins
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    nsitivity and mentally criticized every gift he offered. In the light of my dream, I see his behavior more clearly. It's simple really: He want
    .

    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
    ed to protect his family and to give to the woman he loved.

    In an indifferent and self-absorbed world, it is often wise to question a person's
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    motive. But how many opportunities for community and connectedness would we gain if we looked at a person expecting the highest he has to offer


    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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