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  • Just Other Articles - How's Your Head?

    Right now, as you're reading this article, notice something. Do you have a headache? No? Did you notice that you didn't have a h
    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
    eadache until I asked that question? Stop for a minute and appreciate the fact that you don't have a headache. Celebrate that yo
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ur head feels good.

    Do you find that a little goofy? Yet it's usually only when our head hurts that we wish we'd remember what
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    it feels like not to have a headache. Only when we feel lousy can we appreciate what it's like to feel well.

    That's not a lot d
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ifferent than the way we view our companies or organizations - or really, our lives. We don't really think much about the things
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    that are going well until something happens to throw us off our game. At that point we need a quick fix so we can get back to 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
    aking the health of our bodies or our organizations for granted.

    What might we do to maintain our health, whether that's our ph
    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
    ysical health or our organizational health? What might we do right now - today - when we don't have a headache, to ensure we won
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    't get one - or at least to have a plan if we do?

    Charles Handy talked about the Sigmoid Curve concept in his book "The Empty R
    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
    aincoat" where he said "...by the time you know where you ought to go, it's too late to go there, or, more dramatically, if you
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    keep on going the way you are, you will miss the road to the future."

    The Sigmoid Curve sums up the story and time line of life
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    itself; we are born, we learn and experiment, suffer bumps and scrapes, grow rapidly, and eventually start to decline. It is th
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    e same for product life cycles and biological life cycles. It describes the rise and fall of empires, dynasties, companies, and
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    individuals. It also describes the course of love and relationships.

    But we need to realize that in all these circumstances, we
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    need to manage changes that happen before we begin the downward cycle, otherwise we will be fighting to catch up instead of lea
    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
    ding the way. If we can introduce change when things are going well, we will be able to be on the upswing when the curve starts
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    heading down instead of the downslope.

    What does this have to do with a headache? If we can stop and be grateful and mindful wh
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    en things are going well, we will be much better equipped to manage the times when things aren't going as well ... and, I propos
    .

    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, we won't have as many of those unforeseen headaches in our path.

    Just try it. Stop and notice that you don't have a headache
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    and be grateful. And see where you might be able to be proactive instead of reactive. I bet you'll gain a brand new perspective


    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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