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  • E-Articles - Do Words We Use Really Matter

    I was thinking the other day (No cracks from my friends please.) about the subtle differences between words that are commonly used, sometimes not used or mis-used.
    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

    Let me give you an example.

    I’m sorry. This simple two word sentence can be interpreted so many ways and have so many different meanings for both the person who
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    speaks them and the person who they are directed toward.


    - I forget your birthday so I say I’m sorry.
    - I am late for lunch and I say I’m sorry.
    - I
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    say something out of anger when I don’t mean it, so I say, I’m sorry.
    - I don’t return your call and I say I’m sorry.
    - You are a sorry person.
    - I
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    am sorry you are going through this difficulty.


    The word sorry has two separate meanings;

    Apologetic: feeling or expressing regret for an action that has upse
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    t or inconvenienced somebody, or is likely to do so.

    Sympathetic: feeling or expressing sympathy or empathy, especially because of something that has happened, I f
    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
    elt sorry it had to end that way. Don't start feeling sorry for yourself.

    The words, I’m sorry, when used too frequently or too easily can tend to lessen their emo
    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
    tional value as a verbal gesture toward someone else.

    There’s another way to consider these simple two words.

    Ever had anyone in your life who never said or didn’
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    t have the capacity to ever say they were sorry for anything even though their actions or words certainly warranted this phrase? I have and I can tell you I’d rath
    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
    er hear I’m sorry too often then not at all.

    However, often people feel that they need to apologize or say I’m sorry for things that don’t require these words. In
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    effect many of these people for whatever reason feel that they need to say I’m sorry not for the act but for themselves.

    Let’s say I say something stupid (trust m
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    e I do that a lot) out of ignorance rather than arrogance or malice. It was just a dumb comment. Does it deserve an I’m sorry or a simple apology – I didn’t mean
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    it the way it sounded or I’m just upset and I apologize? My reason or need to say these words, I’m sorry or I apologize will depend on both my self-esteem, your em
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    otional reaction to the dumb thing I said and the circumstances under which they were spoken.

    Here’s the point. In relationships sooner or later we all say and do
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    dumb things not out of meanness, but because of stress, frustration, anxiety, fear or any number of other emotions or circumstances or situations. If your partner
    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
    knows that there was no hurt intended and you have an emotionally stable relationship is I’m sorry necessary every time you do or say something really stupid or hu
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    rtful? It depends again on what you were sorry for and your real intent behind what you said or did.

    Socially it can become a real pain in the butt. I play tennis
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    and I can tell you when I play with someone I don’t want to have to say I’m sorry every time I hit a bad shot. So I have a rule. I say I’m sorry one time to my p
    .

    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
    artner at the beginning of the match and then I never say it again. Most people laugh when I give them my rule.

    I’m not suggesting this strategy in your relations
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    hips, but you might want to develop some similar tactics or rules regarding this issue so you can avoid any negative outcomes either for it’s over use or under use.


    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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