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  • E-Articles - The Arrogance of Age and Other Gentile Aristocratic Attacks

    Respect for your elders is an important part of society amongst human populations a
    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
    nd it makes a lot of sense if you stop and think about it. Of course if someone goe
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    s thru life and achieves very little, makes no significant contributions or does no
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    thing more than take up space, use up supplies and create waste then we must ponder
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    how much respect is truly due.

    You see, respect should not be expected and we mus
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    beware of the one who demands it. Often folks who have been disrespected demand re
    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
    spect or threaten revenge. Is that really the proper attitude to have as one ages?
    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
    There should be a little more use of diplomacy, statesmanship and gentleman behavio
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    r given to the younger generation.

    Indeed, I respect my elders for as much respect
    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
    that is deserved and do not automatically allow them to take the position of autho
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ity just because of age. If they have achieved in life and have wisdom to depart an
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    d live an honorable life, then I am very interested in what they have to say. But i
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    f they demand respect and yet have disrespected me or those around them as they pro
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    gressed on their journey through life then, I ask, is respect to be automatically g
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ranted?

    There is a bit of arrogance which comes with age or position and many olde
    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
    folks position themselves and use their age as tool to promote themselves to get o
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    thers to see their point of view, convince them of something or get them to follow.
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    Fair enough, as everyone seems to use the tools they have to promote themselves or
    .

    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
    their agenda, however, if there is nothing there but fluff, arrogance and unearned
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ego - well do not expect me to get in line. I stand tall and say Dear Sir, Show 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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