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  • Advice Pool - Are You A Drug Addict?

    I realize that for many of you this may seem like a silly question, but as a person who is now completely sober, I think it's an interest
    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
    ing question to ask. If you would have asked me five years ago if I was a drug addict, I would have told you NO. But now, looking back
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    at the situation, I realize that I was. I drank alcohol, quite a bit, and smoked cigarettes and wouldn't have considered myself a drug a
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ddict? Five years ago, absolutely not. But when you truly think about this, I was. Alcohol is a drug, and I drank everyday. Nicotine
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    is a drug, and I choked down a pack of those bad boys a day as well. So at the end of the day, I was a drug addict.

    But this isn't how
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    we're taught to think about this situation is it? We're taught that the term 'drug addict' is reserved for those who engage in things li
    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
    ke heroine, cocaine, or meth, right? We're taught by everyone that these are the real drug addicts and alcohol and cigarettes can be dea
    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
    lt with. So, who teaches us these things? Everything that you see or hear in almost any kind of advertising, that's what. Drinking is
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    construed as "cool" and smoking, while not blatantly called "cool" anymore, can still be seen that way. Besides, smoking just fits so we
    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
    ll with drinking that they both seem to be pieces of the same puzzle. But the bottom line is that alcohol and cigarettes, especially alc
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    hol, are viewed as ways to 'unwind', rather than something truly negative.

    Do you know what I realized after cleaning myself of both pra
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ctices? I was most certainly a drug addict! I was addicted to both of these drugs. How else could I explain the fact that I was more o
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    r less asleep for 10 years? That's what I feel like now. I feel as if I was dreaming during those 10 years. And the bottom line is tha
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    t rather than going to a physician, I decided to medicate myself.

    At the end of the day, I think this question is something we should al
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    l consider, because the term 'drug addict' isn't reserved for the so called hard drugs alone. The term should be reserved for all of the
    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
    foreign substances we put in our body to escape reality. This is why we do it you know? We want to escape that which is real, for some
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    thing that is fake, and it never works in the long run. It most certainly didn't work for me, and I've never heard anyone say that the r
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    eason for their success was the fact that they got hammered every other day, have you? The best definition of addiction that I've ever c
    .

    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
    ome across is this: "Addiction is never getting enough of what you don't want" What could be more absurd than that? Yet, that's
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    exactly what I did for more than 10 years. Chased after what I didn't want in the first place. Just ask yourself, "Am I a drug addict?


    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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