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  • Social Articles - The Final Stages of Enlightenment

    Like me, if you are looking for enlightenment-most of you will have missed the boat-it sailed a very long time ago.

    I retired early in my life-almost seven years ago. Like many I spent much of my life working and raising a famil
    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
    y or two. I reached a point at about 50 years old when I decided I had enough. Actually I decided that long before I retired. I knew there had to be something more than what I was doing. Certainly I didn't let any moss grow under
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    my feet. I owned several businesses and worked for a few. My vocations were highly varied, ranging from electronics, to fur trapping, to writing and more.

    I have several children and have had many lovers and relationships. My l
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ife has always been built around people and yet I am very reclusive and absent from friendship circles and social interaction. People who know me don't understand that, thinking just the opposite-when it's business-I'm right in t
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    here. Most of this reclusive ness is self imposed. I have a really poor memory when it comes to names. I won't remember you name ten seconds after you tell me. So, because I have forgotten your name, I will try to avoid you if I
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    see you. I am not sure if I am reclusive because of this or I am forgetful because I want to be reclusive.

    This alienation from people has helped me in the last seven years to give much attention to my reading and writing. I am
    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
    still working part time as a sales person, so I am in contact with people 4 hours a day. I have rationalized my introverted life even further by acknowledging I don't like soap operas, drama, and gossip. I find conversations with
    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
    others filled with much of this stuff. I do not want to always be serious either-I think we all take ourselves too seriously. But conversations don't have to be judgmental, disempowering, or about personalities.

    I have devoted
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    the last sever years to finding enlightenment. It's what I have written about in the hundreds of articles I have on the internet and in my published books. My searching ended some time ago when I realized I was chasing my tail, y
    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
    et I continue to write and I have another book coming out this year (hopefully). I have moved away past my next book already, and have just completed proofing it; I have considered not publishing it because of this. I also remind
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ed myself, although the book is about my journey, others will benefit from it as they have the first one.

    Every one of my articles or books represents another step along my path to enlightenment, and yet all those steps keep bri
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    nging me back to where I started and where I am now. I have not really traveled anywhere.

    Enlightenment is the process, the path-we are all enlightened creatures. Enlightenment is not a place or the end of the trip. It is not po
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ssible to find it because it does not exist. Enlightenment comes to those who know they are already enlightened. It is the present moment of which you are aware of that is real. You do not live in the past, nor can you live in th
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    e future-there is only now--enlightenment is only now.

    The universe is constantly moving and so does enlightenment. It is as though chasing your shadow-every time you move, so does your shadow.

    One can only spend their time loo
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    king for enlightenment and it is something we do, because we can-it is a vocation with no diploma or degree. You will not find the gold at the end of the enlightened rainbow. It is no different than spending a life-time driving a
    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
    cab, healing people, or building skyscrapers-it's just a job.

    Trying to figure out who we are brings opportunities for exploration and exploitation-denying the obvious keeps us looking. All kinds of institutions and beliefs rev
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    olve around the misplaced conception that we are not really who we are. Many people will take advantage of this belief and make money off your ignorance. Life is all there is-it is this moment and your circumstances-this is enlig
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    htenment.

    Every question I have asked, always leads to another question, and another, and the answer always leads back to me. The mystery of life is created by you-therefore the answers to the mystery you have created always lie
    .

    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
    with you. You are creating the questions and the answers.

    It is your nature to create, and then ask yourself why you did it. The answer always leads back to the question-we do it because we can. As in the innocence of a small c
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    hild, the answer is simple-I did it because! At that point we want to know what "because" is, and we make the whole thing too complicated.

    It is not easy, and for most impossible to accept the obvious-you are already enlightened


    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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