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  • E-Articles - You Have The Ability To Choose

    I recently received an e-mail from a friend of mine regarding choices specifically a person's ability to choose their own attitude of
    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
    mind and how one can look at any situation either positively or negatively and its direct effect on the outcome of that particular s
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ituation. Even though we may not believe it we all have the ability to choose and make decisions, even though we may not like the 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.

    oices presented.

    My question is what choices will you make today, tomorrow and in the future. Are you going to make different choic
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    es regarding yourself, your family and your business relationships? Remember, on planet Earth if we are not moving forward, eventual
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ly, the world will leave us behind. If you do choose to move forward in a positive direction do you have a plan? The majority of peo
    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
    ple I meet don't have a plan and to quote many business management gurus and philosophers “No plan is a plan to fail”.I believe that
    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
    e must start to ask ourselves the tough questions in order to achieve our goals. I have a question that I pose to people everywhere
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    I go.

    The question I ask is “What do you want to be when you grow up”? To date an overwhelming majority of the people I ask answer “
    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
    I don't know”. Isn't it time you figure this one out! As far as I know from all my medical training we have one shot on this planet
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    to create a life we desire and we are not coming back. Therefore it's important for us to make decisions that will lead us in the dir
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ection that we desire. Now for the troublesome part for those of you who answered I don't know to the question what you want to be wh
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    en you grow up? You're probably wondering how I figure this out. Lately I've been using the obituary method of goal setting, and tha
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    t is, I ask myself the question, what would I want my obituary page to say about me after I passed this planet.

    Do I want it to say
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    that I was a good parent and husband or do I want to leave a legacy of contributions to mankind. I come up with these answers by uti
    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
    lizing a simple technique I learned from Stephen Covey who says in his book titled Seven Habits of Highly Effective People “Begin wit
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    h the End in Mind”. You need to know what you want first and work your way backwards. This gives you the ability to come up with a
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    clear picture of what you actually want and ways that you can best accomplish and reach your goals.So what's it going to be? Are you
    .

    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
    willing to do what it takes to create the perfect life one that achieves all your goals and dreams? The only thing stopping you rig
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ht now is you. With your ability to choose combined with specific goals and action steps for their accomplishment the sky’s the limit


    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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