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  • Digg It - Why Isn't It Easier When Someone Else Does It?

    A good friend of me recently changed my perspective on a whole lot of things. It was actually in regards to my colicky baby. I got frustrated wi
    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
    th him constantly asking my self (or sometimes crying outloud), "WHAT IS WRONG WITH HIM? Why won't he ...?

    My friend said, "You need to ask you
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    rself what are you doing to contribute to his (fill in the blank), fussiness, screaming in pain, not wanting to sleep in the crib." You are doin
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    something to contribute to his problem, find out what it is.

    This was not a way to blame me. It was simply a fact finding mission. When I thou
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ght about it along these lines, there was always an answer to my "What's the matter with him?" question.

    For instance, he would be screaming so
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    long and loud and seeming to be in pain. When I asked myself, "What did I do to contribute to this?" I would realize that I had just ate a power
    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
    bar loaded with soy protein. For some reason, soy really hurts my babies' stomachs. Since I was nursing, it crossed right over and my boy would
    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
    ractically double over in pain. (He is too young to double over, but you know what I mean)

    Or if he was fussing and wouldn't stop, I asked myse
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    lf again, "What did I do"? and sure enough I would know the answer. I kept him up way long past his nap and now he is overtired. This answer did
    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
    't even tempt me to let him scream it out because I knew exactly why he was crying.

    Anyhow, I think this question of "What did I do to contribu
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    te to this situation" is an excellent tool. It forces you to discover the facts leading you to the underlying problem or concerning issue.

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

    Following aspects would a
    e is one question I have in particular that I am going to leave open ended to all of my readers. I would really like your feedback since I don't
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    have the answer 100%.

    I recently spoke with a guy who is computer sales. He travels constantly all over the world. He doesn't seem to like it.
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    I said to him, "Can't you delegate the overseas sales to someone who enjoys it?" He said, "I did hire someone. He's great. He does all the sales
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    Problem is, he leaves the sales undone so it ends up leaving more work for me to have to wrap up. I'm actually traveling MORESO now that he has
    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
    been hired."

    Why does this seem to ring true for many of us. We hear about the benefits of delegating, so we delegate. And then, somehow, more
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    work is created for us.

    Why is this? Why is it just easier to do work ourselves? I cannot put this thought to rest because I know how powerful
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    and wonderful delegating can be so I refuse to give it up.

    I think the answer to this problem is to go back to the question, "What I am doing t
    .

    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
    contribute to this situation." Could it be the computer sales owner doesn't have a clear protocol for customer sales follow up and accountabili
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ty?" There is an answer to the question and I think it would solve the frustration of "Let me just do this myself. You've made more work for me.


    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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