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  • Main Subject - How to Deal with Unnecessary and Unproductive Resistance

    Understanding that people could possible resist your planned change would
    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
    help to prevent the same resistance later on when the measures are imple
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ented.

    Resistance is seldom a rational issue. It is most often about a f
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    eling people have about management issues and ‘not being involved’ is und
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    r the top 10 causes.

    Take this imaginative case; you are an employee, wr
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ting for a small company and out of the blue you hear about a new measure
    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
    to improve the quality of the copywriting. Let’s say that this measure is
    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
    to do about increasing the size (word count) of articles and by doing tha
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    the quality should improve. A fresh idea presented by management.

    You h
    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 not been consulted for something that is affecting your job and that i
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    sufficient for reasons to resist ... In the end the issue gets solved, b
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ecause you also think that quality is what writing is all about, but you
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ould have liked contributed your ideas (because there are other ways to d
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    al with this problem) before accepting any new guidelines of the manageme
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    t team. That is what you tell your boss and the next time she will addres
    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
    this issue properly.

    Bottom line -- this organization has been dealing
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ith unnecessary resistance, lost productivity (time) without any influenc
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    on the outcome. There are also examples where resistance will influence
    .

    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
    he outcome of the targeted change and in those cases resistance is useful
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    In this case it was just a waste of time for everybody.

    © 2006 Hans Boo


    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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