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    Listen closely. That multiplying noise you hear is the sound of stress accumulating. At this very moment all over America unattended computers, cell phones and other high technology equipment
    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
    is piling up work for their unsuspecting absent human equivalents. We are uneasily greeting the dawn of a new disease: The Stress Epidemic. The offices of stress counselors are jammed with new
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    clients. On the Richter scale of anxiety American workers are suffering earthquakes.

    How much seismic activity are you experiencing — tremors or earthquakes? Well, if you can't imagine how yo
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    will survive the pressure, you're not alone. A survey by Northwestern National Life Insurance Company found that:
    • Twice as many workers consider their jobs "highly stressful"
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    today as they did in 1985.

    • A third of the country's workers will become so burned-out this year that they may need medical treatment or extra time off.

    • Another third will think serious
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ly about leaving their jobs for what they consider less stressful occupations.

    About one worker in seven will actually quit to escape unmanageable job pressure.

    Another study
    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
    onducted by St. Paul Fire and Marine Insurance Company found stress to be a strong factor in worker burnout, illness and lowered performance—a costly price tag for employers. Companies ignore
    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
    he stress-related warning signs. The result: more employees are filing mental-stress claims against their employers. In California between 30,000 and 40,000 such claims are filed each year.

    O
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    e employee benefits consultant sums up the increase in claims by saying that employers avoid the "S" (stress) word. It is a vulgar disgusting word that is not allowed to be said in the place o
    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
    f business. We work harder with fewer co-workers, but employers think that if they do not say the "S" word that their work force will be immune. These businesses may get a wake-up call after r
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ading a Hilton Hotels Corporation Survey: 20 percent of the 1,000 adults surveyed call in sick at least once per year just to relax.

    Today, Americans sacrifice their well-being for long work
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ours and a hectic pace. Experts note that stress at work leads to stress at home. Seventy five to ninety percent of people visiting doctors suffer from stress-related problems.

    According to D
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    . Hans Selye, the “Father of stress,” there are positive and negative kinds of stress. Harmful stress is called "distress." Positive stress is called "eustress" (pronounced YU-stress). Selye s
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ays that stress is continuous, needed, and experienced differently by every individual. But what causes you distress may cause me eustress - much of the response lies within the individual and
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    not within the event.

    Stress is not to be avoided; it is something to be understood and managed. We need to learn to achieve a balance with the proper level of eustress and eliminate the nega
    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
    ive effects of distress. Stress management does not imply annihilation of stress, but managing stress for maximum productivity.

    Isn't it a relief to know that we don't have to find a way to e
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    iminate stress, but just learn to manage it?

    Ideas to manage stress:

    1. Don't sweat the small things.
    2. Reduce noise. Avoid television for at least one hour after getting home from wo
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    rk—most people are overwhelmed by noise during the day.
    3. Unlock your jaw and picture yourself smiling.
    4. Never let your gas tank go below 1/4.
    5. Do not dwell on a project o
    .

    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
    idea—move on and come back.
    6. Change your position—physically, emotionally, socially, or intellectually.
    7. Don't drive fast—it takes more alertness, more readiness to respond and
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    causes more tension.
    8. Examine your personal beliefs that result in frustration.
    9. Learn good time management which includes plans for relaxing.
    10. Ask for help and support


    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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