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  • E-Articles - Relationships - Shying Away From Commitment

    We have come along way now. It is time for him/her to commit to our relationship. Why it
    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
    s not being done is a surprise for me. How long shall we continue like this now? I have
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    said that I want to marry, but I am not getting any firm commitment from him/her. I am w
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    orried about the future now.

    Not ready to commit. Why? Everything looks smooth. The rel
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ationship is old and going strong. There is no one else on the scene except these two an
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    one of the partners is not ready to commit. Why- is it fear or apprehension? There can
    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
    be many reasons. For example if you probe the mind, the reasons may come out as - I am n
    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
    ot sure about how I will stay committed to one person all my life? I will lose my freedo
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    m. Or, I am not sure whether I will make a good marriage partner? I am not ready to take
    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
    what marriage will bring. What if the marriage turns out bad, like so many I have seen.
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    No I am afraid of the whole thing. And I want to wait for some more time.

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

    Following aspects would a
    ple such reasons never end. They will never commit. Ultimately the relationship comes to
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    a nowhere and slowly begins going downhill. What can be done? If you guess that your pa
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    rtner has got some reasons for not committing, the best option is to have a open talk. H
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ave a dialogue. Find out about all possible reasons and argue them out. Talk to him/her
    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
    bout what improvement they want from you. Be with them and don't make them look like a g
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    uilty party. Have a genuine two-way dialogue. Slowly, your partner may come to a state w
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    here he would not hesitate to try and leave future to destiny.

    Discussions always help
    .

    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
    when commitment is not getting made. Being together is very important. Don’t leave the p
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    artner alone in the tension. Share what goes on in his/her mind and show genuine concern


    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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