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  • E-Articles - Are You Depressed

    What Are the Symptoms? You may be ‘clinically’ depressed if you have most of the following symptoms:
    • depressed mood most of the day, nearly every day, that may be noticed by othe
    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
    rs.
  • Loss of interest or pleasure in all, or almost all, activities most of the day, nearly every day
  • significant weight loss when not dieting or weight gain or decrease o
  • ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    r increase in appetite nearly every day.
  • insomnia or hypersomnia nearly every day
  • psychomotor agitation or retardation nearly every day
  • loss of energy nearly ev
  • lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ery day
  • feelings of worthlessness or excessive or inappropriate guilt nearly every day
  • diminished ability to think or concentrate, or indecisiveness, nearly every day
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    >
  • recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide


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

    Combination pro
    epression Test: Below is a common depression test developed by the psychiatrist Ivan K. Goldberg. The test result is NOT a final diagnosis! The scale cannot replace professional help. If yo
    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
    u suspect that you might suffer from depression, you should contact your doctor, no matter what test result you get.



    I have posted this test so you can see whether you have symptoms
    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
    of depression or not and its severity. You can also use the scale to see if you are making progress in your recovery from depression. If you want to, you could print out the test and show i
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    t to your doctor. This might help him or her to assess your condition better.



    The questions below refer to how you have felt and behaved DURING THE PAST WEEK. For each question, ind
    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
    icate the extent to which it is true, by using the following scale:



    0 = Not at all 1 = Just a little 2 = Somewhat



    3 = Moderately 4 = Quite a lot 5 = Very much



    The
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    uestions:
    1. I do things slowly
    2. My future seems hopeless
    3. It is hard for me to concentrate on reading
    4. The pleasure and joy has gone out of my life
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
  • I have difficulty making decisions
  • I have lost interest in aspects of life that used to be important to me
  • I feel sad, blue, and unhappy
  • I am agitated and k
  • dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    eep moving around
  • I feel fatigued
  • It takes great effort for me to do simple things
  • I feel that I am a guilty person who deserves to be punished
  • I feel
  • cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    like a failure
  • I feel lifeless - - - more dead than alive
  • My sleep has been disturbed---too little, too much, or broken sleep
  • I spend time thinking about HOW I
  • tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    might kill myself
  • I feel trapped or caught
  • I feel depressed even when good things happen to me
  • Without trying to diet, I have lost, or gained, weight
  • 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
    >



    Now add up your total score. According to Goldberg if you scored: 0-9 Depression is unlikely
    10-17 Possibly minor depression
    18-21 Possibly on the verge of depression
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    r> 21-35 Possibly minor to moderate depression
    36-53 Possibly moderate to severe depression
    54+ Possibly severe depression





    Please note that this test result can
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    not give a you guaranteed assessment of your mental health. You should always consult a doctor if you feel depressed or if you feel that worries and anxiety have taken over and affected the
    .

    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
    activities of your daily life. Seeing your doctor and getting the right treatment quickly will dramatically improve your life, and the life of those who care about you.

    I sincerely hope thi
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    s helps. Don’t forget you can freely post your stories and feeling of living with depression and low mood on SpeakOut’s Forums (http://www.speakout.biz/forum).

    I wish you the best of health


    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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