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  • Your Space - Communication: Feeling Whole Again by Reaffirming What You are Truly Feeling

    We know, as people despite geographical location, that relationships, especially with those we love, are not always a picnic through the park. We have our good times and our bad times; clich?, clich? as we circle through a myriad of emotions that can leave us at the whim of our own destruction or affirmation of who we are and what we stand fo
    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
    r.

    Digging a little deeper, how many times have we experienced a range of emotions from unhappiness, disgust, anger, crazed yelling, quietness to tears and sleepless nights only to face the daylight without so much as a resolution or honest conversation with the person you love regarding issues that are clearly bothering you. Instead of feel
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ing better, you feel out of touch with yourself, the world, your day and the person you love.

    Sadly enough, I have watched people experience these range of feelings that take many hours or days for them to overcome; in some cases, a week or more. Stubborness, refusing to “give in” to “weakness”, there is a period of loss time, precious time,
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    before reconciliation and understanding occurs so that a re-connection can be made and the relationship you cherish is ignited once again.

    Let me reach out to you now and state that this simply does not have to occur. At the very core of who we are, we know we are emotional human beings who feel every imaginable feeling... we feel. I can sm
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ile a bit here because I have, not too long ago, told my husband this. We feel happiness, joy, anger, love, passion, sadness, discomfort, contentment... we feel. But when the wheel starts turning and you find you are going in a direction that is not being recovered quickly... the shadows cast upon you have turned from grey to black with no l
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ooking back…it’s time to put those emotions in check with the reality of what you are truly experiencing.

    Past the emotions, we are also thinking beings. We feel, but we always connect our emotions to what is occurring right then and right there in your present life. We have past experiences, to be sure, that somehow mingle into our current
    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
    experiences, but our current experiences are action moments shaped by the hear and now…what you have now and the choices you make now in your world.

    With the past set aside, often our “stormy experiences” stem from our need to express how we are feeling, what our needs are, and our hopes are. Feeling vulnerable to expression of ones deepest
    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
    desires and thoughts can grip the very heart of a person who spends much of their time defending who they are or, on the opposite side of the tracks, who they feel they need to be in order to be validated by loved ones, peers, co-workers and the like. But, like the cartoon character Popeye said “I am what I am and that’s all that I am.” You
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    do not need to prove yourself to anyone, you just need to be. To live, to feel, to express, and to reach out to those you love when that ground begins to shake. To live honestly, to express honestly... there is no better way to live than this.

    A client of mine has had quite a bit of a challenge communicating with her son. Her son is 14 and
    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
    going through some changes, seeking his ground for independence. With her frustration, confusion, and sadness over the strain in their relationship, what began to surface was the fact that her son was growing up and she was feeling her role as a loving mother and caretaker was being swept away under the carpet, leaving her missing the open an
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    d carefree experiences she once had with her child. The son, on the other hand, did not understand why his mother was so frustrated with him. He was living his life, doing his schoolwork, and for all practical purposes, conducting himself as any typical teenager.

    Ah, the teenage years. Well, when the mother and son sat down in my office an
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    d talked, the mother revealed her need to be more a part of her son’s world and that with him growing up it appeared that he did not need her as he once did. She explained that she missed spending time with him and wanted to be able to take in a movie or play Play Station games as they once did before the school season started and his relatio
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ships began to build once again with his peers. The son stated that with all the homework that was being given, after he finished his schoolwork all he wanted to do was go to his room and read and watch a little TV before he went to sleep. In reality, he missed having fun with his Mom and siblings as much as his Mom missed spending those qua
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    lity moments with him! After all was said and done, we discovered evenings were really rushed for all family members and steps were taken to recommit to family dinners where quality time could be experienced, where weekends were given “family time” priority instead of running errands and feeling rushed during Saturdays and Sundays with Mom an
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    d Dad partnering in with the son to become more in tuned with what his scholastic life was like.

    Open up and share your heart with those you love. Feel free to be who you are and do not apologize when you do. Yes, we feel all emotions. Take the time needed to understand why you experience those stormy moments and reach out instead of retre
    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
    ting into your corner of the world. Often, a hug, just one moment of connecting with the eyes and honest words expressing your feelings can bring the relationship back on track in the wink of an eye.

    Steps to Calm the Stormy Seas

    1. Breathe- the challenge is not going to swallow you up. There is an answer looming in the distance, reach for
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    it.

    2. Remember that a loved one is not the enemy. If you love them and feel any emotion for them, they are worth the time it takes to talk…be true to yourself for yourself and for the person whom you desire to reconnect with.

    3. Hug. Close connection is important. If not a moment to hug, how about holding hands or quietly going for a wa
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    lk? The last thing you want to do is walk away in anger or give the cold shoulder…remember, you love the person no matter what you are experiencing.

    4. Communicate with honesty. Your feelings are signals. Only you know what is truly causing the storm. Express what troubles your heart and soul. Ask questions, listen for answers and move f
    .

    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
    rward towards reconciliation.

    5. Be able to receive honest communication. Allow communication to flow both ways. Move forward towards solutions; never let the storm rise again once you are on the path towards calming the waters. Be committed to getting to the heart of the matter because you love and care for the other. Your strength and d
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    etermination out of love will help the other reach out to you in turn.

    6. When the storm subsides, move forward. Moments are wasted recalling storms…move forward to a brighter and fulfilling future.

    Remember, I am here to help you any way I can….live in the present, move towards the future and know storms come and go, but love lives forever


    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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