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  • Your Space - Ability, Motivation, and Attitude

    “Ability is what you're capable of doing. Motivation determines what you do. Attitude determines how well you do it.” Lou Holtz

    There are three primary aspects of your life that will determin
    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
    e whether or not you are successful in your endeavors. You will not be successful if you have only one or two. You must have all three working together. Consider them like the three legs of 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
    “stool of success.”

    Ability – the level at which you are able to actually do things. Your skill level. If you have a high level of skill, that’s good. And the better you get, the better it wi
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    l be for you. To the degree that you can perform your actions at higher and higher skill levels, the more and more success you will find in your chosen field.

    Motivation – the level at which
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    you are able to find “a reason to act.” This is the internal drive that you find that enables you to exercise your abilities. To the degree that you can find a way, or ways, to keep yourself m
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    tivated, you will see yourself right in the thick of things, carrying out your actions to the best of your abilities and succeeding accordingly.

    Attitude – this is the mental state that you h
    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
    ave while carrying out your actions to the best of your ability. It is the way you view the world around you and choose to see it, either positively or negatively. To the degree that you can m
    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
    intain a positive attitude about yourself, others, and the circumstances you find yourself in, you will see yourself achieving greater and greater things.

    “But Chris, can’t I get away with ju
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    st two?”

    No.

    What if you have high skills and motivation but a rotten attitude? People will stay away and hinder your success. What if you have a good attitude and motivation but poor skills
    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
    People will like you, maybe even root for you, but go to someone else with the skills they need. What if you have great skills and attitude but no motivation? Well, you’ll be sitting on the c
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ouch like a lazy slug while the go-getters are out there making your money and achieving your dreams!

    No, it takes all three. So let’s ask some questions: Ability: How highly skilled are yo
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    u? Is your skill level holding you back? How so? What could you achieve if you just took your skills to the next level beyond where they are right now? How would improving your skills improve
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    he bottom line of your success?

    Motivation: How motivated are you? Why do you answer that way? What would your spouse or close friends say? Would they say you are as motivated as you say you
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    are? Why or why not? Why do you have the level of motivation that you have? What could you do to find a higher level of motivation? What would happen if you became super motivated for the next
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    period of your life. What great things would happen?

    Attitude: Do you have a good attitude or a poor one? How would you rate yourself? What about when things go wrong? Are you more of an opti
    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
    mist or a pessimist? What would happen if you took your attitude to the next level for the next 60 days? What if you just chose to have an incredible attitude? What would be the ramifications?
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust

    “The world cares very little about what a man or woman knows; it is what a man or woman is able to do that counts.” Booker T. Washington This is so true. People will judge you on what you ac
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    complish, not what you know or what you talk about. In fact, if you know a lot or talk a lot but do not accomplish anything, people will wonder what happened. So the question is whether or not
    .

    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
    you will take the actions necessary to deliver on your potential. To do so, you will need to focus in on the three legs of the stool of success: Your ability, your motivation, and your attitud
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    e. Take some time this week to give some serious thought to these three areas. Your success depends on it! And when you have done some reflection – put the conclusions you come to into action


    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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