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    Each of us has our own set of personal values; these are the things which we believe are important, which motivate us and to which we give priority. If I
    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
    asked you what your personal values are, the chances are that you would struggle to find the answer. You would not be alone; in fact the majority of peopl
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    e would find it hard to answer this question satisfactorily.

    The reality is that most of us are not fully aware of our own personal values. This is the s
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ame as saying that most people are not aware of what is important to them.

    The problem is made worse by the fact that not only ourselves but also other p
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    eople and other institutions have their own set of core values. People such as friends, partners and employers, each have values that have an effect upon
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    us and our lives.

    Consequently, we may find ourselves living our lives according to the values of other people instead of following our own values. For e
    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
    xample, in the work place, you may find yourself following the values of your employer;- good timekeeping, increased production, profits, sales targets et
    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
    c.. Yet how many of these values would you feel fitted with your own core values? Furthermore, if you spend your life meeting only the values of your empl
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    oyer, do you feel that would be a happy life?

    Do you feel that meeting only the values of your employer would lead to a successful life? Well, that would
    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
    be possible if you measured your success in terms of achieving targets set by your employer and gaining more pay or promotion as a consequence. But just
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    look at how many people go through life with the feeling that true success is much more than earning money or promotion. People increasing measure success
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    by other criteria. For most people, success is measured by something more than or other than financial gain. So for most of us, following an employer’s v
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    alues would not lead to what we feel to be a successful life.

    This is not to say that the values of others are not important. They are important and it i
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    s important for us to recognise these values especially when they impinge or affect our own lives. However, it is more important for us to recognise our o
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    wn personal core values.

    It is by our own core values that we measure our success and happiness. It is they that tell us what is important in our lives.
    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

    As a Life Coach and counsellor, I encounter many people who are unaware of their own core personal values. I am able to undertake a values elicitation e
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    xercise with these people to help them discover their core values. The outcome of this exercise is often very revealing for them, it gives them an insight
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    into what they really value and what motivates them. It can often indicate to them where their lives are not in accordance with their values and how they
    .

    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
    are striving to fulfil someone else’s values. Usually, this is also a source of stress or frustration in their lives.

    So I would recommend anyone who is
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    looking to discover their own personal values in life to consider the services of a life coach. Your values really are your key to success and happiness.


    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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