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    Whoever coined this phrase is a genius. Life finds ways to dish out exactly this- the good the bad and the ugly. At times all
    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
    in one day.

    Optimists tend to see the good, the beautiful and the positive. Let the negativities slide off, like a drop of wa
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ter on a waxed surface. Let it go. Life is too short to spend in misery. Believe in the power of positive thinking.

    This is g
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ood.

    Pessimists find fault in everything, even in themselves. Nothing is right, no matter how hard they try, they are not getti
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ng anywhere in this life. They see no beauty in this world, much less in their relationships.

    They are unlucky, no matter how ha
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    rd they try, nothing works for them. They wallow in the world of negativities, they sink deep into their misery. They feel forsa
    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
    ken and forgotten. No one cares for them.

    This is bad and ugly.

    Who has not had moments of the good, the bad and the ugly? N
    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
    o one is perfect. The beauty of life lies in its unpredictability, its impermanence , yet life offers opportunities. It is ours
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    for the taking. But, inaction will bear no fruits.

    Change is part of life, it embraces all aspects of life- physical/ material,
    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
    mental, emotional, intellectual and spiritual. It’s how we respond and react to changes that define what we have learned from
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    life.

    Change can be bad and ugly, but,lessons learned,can make life beautiful.Loss and grief are stepping stones to go a notch
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    higher, to reach deeper within. Grab the chance to re-assess, re-evaluate and react to the changes that follow loss and gri
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ef. There is something good that can come out of what’s bad and ugly.

    Imperfections tend to be universal, not defined by race
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    , creed or social status. As we go through this life, we start to accumulate emotional baggage.

    We meet demons that haunt us, a
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    t times very ugly.

    Somewhere deep in the psyche is the inner child that begs to be acknowledged, so that one can move on. This
    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
    can cast an ugly shadow. Confront it, acknowledge it, deal with it. Bring out the good that will surely benefit you, allows
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    you to move on freely and do away with hang-ups.

    Sometimes, life takes us to a masquerade. We wear masks, suited for any occa
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    sion. Peel off the layers of hypocrisy, get rid of the many masks that cover or hide the real you.

    These are bad and ugly.

    L
    .

    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
    isten to yourself, be more aware of your thoughts, give yourself a few minutes each day to re-align your thoughts with the bri
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ghter side of life. Feel the inner peace. Savor it.

    Let the good in you shine forth and make a difference in this world.

    E N


    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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