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  • E-Articles - How Will You Make a Difference in 2007?

    Perhaps the greater question is, why are you here? The philosophical issue of man’s existence on this planet comes to mind. We are here for a reason. Think about it. You apparently have one crack at life and a chance 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
    do something memorable. That is, unless you think that watching television eight hours a days is more important than making a contribution to humanity. Because I am somewhat psychic, I already hear you whining that you a
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    re too poor, too stupid or some other lame excuse to really make a difference. Fine, let’s consider what I’m actually asking you to do.

    It’s not a matter of inventing a new product or solving life’s riddles. It could be
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    as basic as raising a family where each child becomes the best they can. Or volunteering to help the community in some benevolent manner. You might be a mentor or role model to someone who has taken the wrong path in th
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    eir life. Being a dependable friend or relative can also contribute to society. These are things that anyone can offer and take little or no money; only some time and commitment. But, to those of you who love New Year’s
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    resolutions, why not take a bigger leap of faith? Try something more demanding and impacting.

    Have you ever dreamed of having your own business? If not just to make more money, than to be your own boss and control your
    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
    own potential. Or maybe you have an idea for a new invention that would benefit the masses. You may occasionally think about these ideas but realize; (a) they are too expensive, (b) they would require too much time, (c)
    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
    ou are not smart enough to pull it off, (d) you are too lazy to follow through, or (e) you probably have a very small chance of success. So instead, you continue to languish in front of the TV munching on a bag of chips
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    and watch the world pass you by. Shame on you.

    Did I mention that you are only on this planet for a lifetime, whatever that may be? When or what other opportunity will you have to fulfill your dreams? Who is going to co
    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
    me by your house one day and say, “I’ll do all the work, finance your project, and make it happen,” because they are your guardian angel? Rather than buy that lottery ticket or daydream about what might-have-been, why no
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    t really do something about it?

    The number one New Year’s resolution is to lose weight. In modern times, it’s been that way for decades. Every January, the weight-loss clinics and fitness clubs are brimming with hopeful
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    members. By March, they are back to normal with the regular members. Why is that the case? Because human nature dictates that most of us acknowledge the problem of obesity but few will actually diet and exercise to achi
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    eve our goal. It’s too hard and requires self-sacrifice and determination. That’s also true of business.

    The world if full of new businesses going under because of poor planning and no long-term commitment to success. I
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    t takes deep pockets and faith to move forward with a successful business. Four out of five new companies will fold in the first five years because they didn’t do the basic things to make it in the real world. But it ju
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    t requires some planning and fortitude to get past the obstacles. Of course it’s far more easy to not even try than attempt to start a business from scratch. Or design and market a new product. Or whatever you dream abou
    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
    t doing in the future. Will you enter 2008 and look back over the previous year and wonder what might have been? Or is it time to finally put your hopes and desires on firm footing and map out a plan of action?

    Don’t al
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    low another year to pass you by. It might require getting a partner, taking out a loan, forming a small group of investors, or bringing in experts and giving them part ownership. But part of something great is better tha
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    t having all of nothing. You can make your life meaningful and exciting if you choose to do it. No one else can live your life for you. Depending on your situation, you can pick something simple to begin with and then gr
    .

    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
    ow it into something amazing. Perhaps it might be a hobby that becomes a business. It’s your decision and you’re the one in control of your own destiny. You’ve already wasted five minutes by reading this article, so stop
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    reading. Move away from the keyboard, grab a pad and paper and write out your plan. Once it’s written, it becomes more real and remember you can make a difference in your lifetime. It’s begins by taking this first step


    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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