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  • Digg It - Coming to Terms with Your Industrial Strength Difficult Person

    Call it bad vibes, gut reaction, instant dislike, or hitting a major hot button. Truth be told, there are just some people we do
    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
    n't like, don't want to associate with, and want to avoid. But, when they're our co-workers, we can't avoid them. We may have to
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    work closely with them, day after day, until we successfully complete the job.

    If you are stuck with your difficult person, it ma
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    y be time to let go, to change how you feel about and deal with your own industrial strength difficult person.

    Letting go doesn
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    t mean excusing bad behavior or denying how we feel. It means detaching ourselves from feeling bad. Letting go means not letting
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    the other person determine how you think and feel. You can detach by taking charge of how you see them and yourself.

    Ask yours
    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
    lf:

    1. Who else has the same issues and problems with your difficult person that you do? How is this third party like you? Not
    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
    like you?

    2. Who doesn't seem to have problems with your difficult person? Again, ask yourself how they are like or not like you.
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    What do they do, how do they relate to your difficult person that doesn't seem to trigger the same feelings or problems you ha
    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
    ve?

    3. Who does your difficult person remind you of? They may well have a different name, a different face, but their behavior,
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    attitude or style is familiar to you. Why? They remind you of someone else, someone you don't like.

    Take a mental leap to the nex
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    t level. Start thinking of the larger issues. Is this a question of values, personality or attitude that stands between you and
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    our difficult person? Or, are your differences in professional focus or training? Does age or culture play a role? Or, do you st
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ill have unfinished business with your difficult person, and are letting it get in the way?

    By identifying who else does or doe
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    n't have trouble with your difficult person, you can see other ways other people have of dealing with the person you find so tro
    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
    ublesome. You may well find an alternative you can use for yourself. Or you may decide not to do what you see others do.

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

    Professional from academic institutions, pharmaceutical industries, health care indust
    ective of this exercise is not to change the other person, or minimize their difficult behavior. Or even to become buddies.

    The
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    objective is to see the other person and yourself more clearly, and detach yourself from upsetting feelings.

    By understanding th
    .

    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
    dynamics of how a difficult person "makes" you feel, you can choose to take charge of your feelings.

    Copyright © 2005 Pat Wikl
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    und. All rights in all media reserved. This article may be reprinted so long as it is kept intact with the copyright and by-line


    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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