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  • Useful Articles - I Flunked the Army - What Are YOU Gonna Do?

    It’s true, oh it’s true! I flunked the army. Well, I didn’t get kicked out. I made sharpshooter, I got t
    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
    o be corporal in the days before tech ranks. (I would have made sergeant except for that blankety blank major who correctl
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    assessed that I would have made a lousy non-commissioned officer.) The army didn’t say I flunked, but I realize the
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    terrible mistake I made. I resisted.

    I can hear a chorus of “Yay!’s” out there. Callow youths admiring
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    the rebel. Nuts. (Is that word allowed on the internet?) I lost out on some of the greatest opportunities of my life becau
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    e I was angry and hostile to the army. I have to say that the army, at least in 1952-3 was not a kindly institution to its
    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
    inmates, at least not to the lowliest draftees like me. But it wasn’t a lot worse than P.E. in high school.

    I don&r
    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
    squo;t regret much in my life, but I can’t help thinking what a dope I was to not get the most out of my army experi
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    nce. Sort of like going to college and not studying if you can imagine such a thing. They offered me OCS. Officer’s
    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
    andidate School. I could have been a lieutenant and been the first to be shot at Pusan. I told myself I should not accept
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ecause I would then be in the reserves forever, but I think the truth was I was scared that I couldn’t do it. Don&rs
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    quo;t tell anybody I said that.

    I had it so good, so easy, I’m almost ashamed. Almost.

    I was sent to Japan during
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    he Korean action. Nobody seems to want to call it a war. In Japan, my regiment, General Custer’s 7th Cavalry, (I was
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    so proud; I can’t think why except that we got to wear a yellow ribbon) was in reserve. If there was a need, we woul
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    d trot, or rather steam right across the straits and go into combat. But I was behind a desk. I didn’t have to get m
    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
    ddy every day and all that stuff the real troops were stuck with. Still I was angry and resistant. I had the opportunity t
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    learn to speak Japanese and I frittered my time away doing crossword puzzles.

    I could have sopped up the Japanese cultur
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    e, I could have become a family friend, I could have been a contender, I could have been somebody. (In case you are too yo
    .

    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
    ng to know, that’s from “On the Waterfront, Brando).

    So, if you are going into the army give it your all, lea
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    n everything you can and don’t be so resistant. Do I sound like a recruiting sergeant?

    No way, I only made corporal


    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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