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  • Advice Pool - MRI Scans - What to Expect

    Over the past 2 years I have been suffering with occasional back problems. Mainly in the lower lumber region. After numerous visits to the Doctor he
    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
    suggested I should have an MRI scan.

    MRI Scans are fairly new to the medical world, first appearing in the 1980's. They create a certain amount of
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    a apprehension in patients as you are inserted into a tube and your body is scanned by magnets firing pulses into your body and data is built up ba
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ed on the response time from fire to receive.

    A lot of people get clostrophobic and are frightened to death at the thought of being stuck in a tube
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    for up to 30 minutes.

    Well today I had my first MRI scan. I was a little apprehensive, and I tend to suffer a little from Claustrophobia. After ch
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ecking in at reception, I was told to take a seat which I duely did. There was an older lady and her husband sat nearby, she was crying. It transpir
    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
    d that she was so claustrophobic that she had refused to have the scan done. I felt sorry for her but this didn't help my own situation one little b
    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
    it. After a time her scan was rescheduled and she left.

    My name was called, I was taken to a changing room and told to put a gown on. You know the
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ones that open at the back which you can never tie properly and you end up showing your back side to everyone. I was then led to the MRI Scan Room.
    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
    I led on the bed of the machine and was given a panic button and some ear plugs. The ear plugs are definately worth every cent as it gets very noisy
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    in there. Once I was comfortable, the trolley/bed was pushed into the tube with me on board and I was told to lay still. The voice over the interco
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    m said I was to recieve 7 scans on my spine lasting 4 minutes each. She then said lay still as the first scan was about to start.

    So there I was le
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    on an uncomforable bed inside a tube, laying as still as possible, bearly beathing, when it started. To say I was feeling apprehensive was an under
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    statement. The scan started with a few loud bangs and I almost hit my head on the ceiling of the tube, as I was not expecting the level of noise tha
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    t I was suddenly subjected to.

    This level of noise continued for the best part of 30 minutes, with a brief pause between each scan. The feeling was
    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
    quite bizarre, as I could hear this banging noise constantly, combined with a feeling of being pulled downloads as each magnetic pulse entered my bo
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    dy. I just closed my eyes and tried to stay as still as possible.

    30 minutes is a long time to stay perfectly still with a constant banging going o
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    n in your ears, and my arms were slowly going numb. Then it was all over as quickly as it began. I was pulled out of the tube, and made my way back
    .

    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
    o the changing room, with my back side on show. I'm sure those gowns are designed to embarrass you.

    So MRI scans, are they as scary as they make ou
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    t, well for me, you bet. I hate being couped up in confined spaces and I would challenge anyone who thinks differently, even the most hardened soles


    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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