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  • References - Stressors - External And Internal

    Stressors are agents that cause stress. Stressors can be divided into two broad categories:


    · External
    · Internal

    Ext
    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
    ernal Stressors
    External stressors are the sources of stress that we are aware of around us. These stressors are things tha
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    t create a situation of perceived threat in our minds and bodies. Over the last few years a lot of research has been done on ext
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ernal stressors. These stressors can affect us in various settings- at work, at home, while driving and in a social setting. We
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    are all free sprits in Nature. Anything that constraints our freedom of expression, thought or action creates a situation of str
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ess that out bodies and our minds would like to change. It results in a feeling of unhappiness and discontent. For example, the
    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
    same home can be a happy place or a stressful place. If things do not happen according to our desires at home, our wishes are un
    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
    ulfilled and we feel stressed.

    In the workplace, our expectation of our work, our employers, our colleagues and our own commitm
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ents, if unfulfilled, create a situation that our mind perceives as a threat. We find ourselves helpless and unable to change th
    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
    e situation. Our free spirit is stilted. We feel the ‘pressure’. This is stress.

    Internal Stressors
    Internal stressors are
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    the stressors inside us. These are stressor that have been in our minds and bodies for many years of our lives. These stressors
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    exist in the form of our genetic loading. They are also restrictions that have been imposed on us by our parents, our teachers
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    and various authority figures that have taught us what to do and more importantly, what not to do. Such internal stressors remai
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    n in our bodies, unknown to us, in the form of emotions. According to recent researches done in the United States, such emotions
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    exist in our bodies in the form of neurochemicals called neuropeptides. Neuropeptides are laid out in our cell systems in such a
    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
    manner that the patterns are hard to delete. Such patterns, when laid out with our emotional experiences, persist for our lifet
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ime. In this form, stress is stored in our bodies. These stressed or negative emotions or neuropeptides are organized in such a
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    way as to affect our perception, our thinking and our behaviour. These stresses become chronic.

    The interaction of the external
    .

    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
    and internal stressors and the internal stresses creates what we call stress. The internal stressors mentioned above, when inte
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    racting with the external stressors (environment), create arousal in our body systems. The internal stressors then become stress


    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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