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    The most important investments require time. Setting and achieving a resolution requires focus, effort, and commitment. Changing old habits and developing new ones won't happen overnight. The following four guidelines are meant to help you achieve all of your New Years Resolutions:

    1. Focus on one resolution at a time: Divide and conquer the activities to achieve your desired
    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
    results. Break larger tasks into smaller ones – each of these make up your Personal Resolution Road map, a path to achieve your goal.

    2. Create a sense of accountability: Designate a friend, mentor, or companion for sharing successes, monitoring progress, and offering support. The benefit of involving others in your goals and plans is instant access to experience, knowledge, 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
    nd wisdom—it also raises the bar of responsibility.

    Research indicates that one of the qualities of those who are successful at making changes is that they have excellent support systems. Many of those who make resolutions never tell others about them. Consciously or subconsciously, that way if they fail no one will view them as a failure.

    Communicating your resolution and
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    intentions actually increases your accountability to the behavior. From the very beginning it is important to share your objectives and goals with those around you so that you can enlist their support. Knowing that you are accountable to someone other than yourself will help to keep you on track.

    3. Persist until completed: A resolution achieved is a stunning example of consi
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    stency and hard work. If you fall behind schedule or are sidetracked for any reason, refocus! Just don't give up! Don't surrender to temptation, difficulty or temporary failure. Persist until you achieve the goal.

    4. Cultivate personal integrity: Integrity gives you the oxygen needed to cross the finish line of accomplishment. Your commitment determines your level of success.
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    This commitment boils down to two essential tactics: daily action and review.

    Resolution Beginnings

    The nuts and bolts of achieving any resolution are invariably the same. Neither the size of the resolutions nor the person achieving it matters. Successful New Year's Resolutions consist of the following:

    Clear Purpose – For a dream to become a goal, it must be specific. Being
    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
    thin is an image, losing 10 pounds by March 1 is a true resolution. Be clear on what you want to achieve.

    Make a New Years Resolution that you have a real, bona fide intention of keeping. The truth is most people have not made a genuine, serious, no-kidding around- I-really-mean-to-do-this New Years Resolution!

    In Writing – Describe precisely what you want, how you will earn i
    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
    t, when you will have it, and the benefits you'll receive from achieving your resolution. Write the details, but don't make it complex. When you put it in writing, you increase your chances of moving to the next step and increasing your level of commitment.

    Your mind, while blessed with permanent memory, is cursed with lousy recall. Writing your resolution goes a long way towa
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    rds achieving it.

    Commitment – Without commitment, you can say, “Farewell dream. Adios potential. Toodleloo success. Hello Mediocrity!” Your resolution will find a more deserving soul: someone with courage, character, conviction... commitment.

    Commitment is not only habitual but also essential — it moves you ever closer to your resolution and ultimate success. Commitment is t
    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
    he heartbeat of your goal.

    Accountability Counts – commitment means you own it. You are responsible for taking the resolution that's on paper and turning it into a desired outcome. Owning it means tasking responsibility for changes, risks, failures, and successes.

    Creating Your Resolution List

    Write down your list of New Year's Resolutions. Get them all out of your head and d
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    own on paper.

    1.__________________________________________________

    2.__________________________________________________

    3.__________________________________________________

    4.__________________________________________________

    5.__________________________________________________

    6.__________________________________________________

    7.____________________________________________
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ______

    8.__________________________________________________

    9.__________________________________________________

    10.__________________________________________________

    Focus, Focus, Focus!

    Does one resolution stand out? One that you are ready to go after. Focus on this one; you can replicate the process later.

    My #1 Resolution is:

    _____________________________________________
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ________

    Resolution Validation

    Next, validate your chosen resolution's importance. For each question below, ask yourself if you're getting a green - go, yellow – caution, or red - stop signal.

    If a caution or stop signal pops into your head, stop to ask why. It might mean that this resolution isn't the right one to be focusing on. The validation test will keep you motivated a
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    s you continue on your resolution road trip.

    If the validation questions show you that this is the wrong resolution for now, start over. Return to your original list, and work through the process once again. It is wiser to focus on the right resolution than to start one you're not committed to.

    Write down what comes to mind as you read through each question. These notes will
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    serve as a motivational tool for you when you are in the middle of your resolution plan.

    Is This Resolution Part of My Personal Mission?

    _____________________________________________________

    Does this resolution align with my mission? How?

    _____________________________________________________

    How does this resolution align with my values?

    _____________________________________
    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
    ________________

    How will this resolution bring me closer to living my mission?

    _____________________________________________________

    Is This Resolution Really Me?

    _____________________________________________________

    Is this resolution authentic?

    _____________________________________________________

    Can I envision myself accomplishing this goal?

    ____________________________
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    _________________________

    Is it a habit that I can incorporate into my life?

    _____________________________________________________

    Am I The Owner of This Resolution?

    _____________________________________________________

    Is this MY goal?

    _____________________________________________________

    How can I take complete ownership of this resolution?

    ________________________________
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    _____________________

    Is This Resolution In My Control?

    _____________________________________________________

    Is this a resolution I can actually achieve?

    _____________________________________________________

    Is it within my control or someone else's?

    _____________________________________________________

    What do I control about this resolution?

    ______________________________
    .

    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
    _______________________

    What do I not control?

    _____________________________________________________

    How Will This Resolution Stretch Me?

    _____________________________________________________

    Is this a resolution that will make me grow?

    _____________________________________________________

    How will it help me learn new things?

    ________________________________________________
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    _____

    By investing your efforts in these guidelines that lead to successful resolutions, you give yourself a launch pad for starting your new year and your new life.

    I wish for you a New Year of health, wealth, and happiness. I encourage you to pursue your resolutions with open arms and to believe deeply in your ability to enjoy the rewards of resolutions and dreams achieved.


    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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