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  • Just Answers - The End of the World

    The end of the world is coming. Scientists say that the sun will flare out in the future and envelope our entire solar system and all of its planets, burning them to a crisp! This sort of thing is happening now 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
    n other parts of our universe, so it’s not unusual, The earth is not unique. This planet we call home is a tiny dot revolving around a star, and this star is merely one of billions of suns clustered in a single g
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    alaxy. Multiply this one galaxy by uncountable billions of galaxies in possibly uncountable trillions of universes and the mind must take pause. Who can know what other unimaginable things exist in this material
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    world, let alone the worlds we can’t comprehend? The immensity of time and space seems endless, beyond conception.

    So eventually, our earth will no longer exist, and we are helpless to avoid this unless of cours
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    e we can colonize intergalacticly, otherwise, all of our accomplishments will one day be erased. All things fashioned by our minds in physical existence, our art, our philosophy, our religions, will be lost forev
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    er. What accomplishment can survive this?

    Even if we colonize the entire universe, there are theories that the universe itself will crash in time, as the big bang turns into a big black hole. But maybe by then w
    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
    e will come up with some other way to save ourselves . . . maybe not. We must bow to our vulnerability as organic forms.

    So, understanding all of this, we look to the heavens, which we hope is above the chaos do
    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
    wn here. After all, if there is no spiritual dimension above, alongside, or under our universe, then atheists certainly have a point – at the end of life is the big eternal sleep! But our flimsy mortal senses can
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ’t experience the spiritual dimension to the extent that we can say, “There it is!” So, we look to a religion that will insure our survival, a religion not too difficult, because we can’t fail in this. We therefo
    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
    re choose a religion that’s easy, we believe whatever they tell us, we take it as our truth, and we secure our little selves.

    But are we securing ourselves . . . or fooling ourselves? Fear can cause us to do des
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    erate things and believe almost anything. Our deepest fear is that we will disappear, and we can’t let that happen; we’re much too important. Therefore, we follow whatever mysteries, miracles, doctrines, rituals,
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    or magic that will insure our immortality. And things are good again – but when viewed from an unbiased perspective, all of this is very immature and childish.

    Regardless of our strong beliefs, and no matter ou
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    r spiritual experiences, we must honestly admit that we don’t know. We can’t know Reality, and therefore our illusions become our comfort zones. It’s all based on faith, and faith depends upon whom we believe.

    T
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    he things that we can know for ourselves can only become known internally. External beliefs become irrelevant. We can know, for example, that the immortality of this self, a self that we think is so important, is
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    irrelevant. The self is but an illusion. Think about it; if our self does not exist, in the way we believe it exists, and has never existed, except in our minds, what is left to become immortal? Nothing. It’s on
    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
    ly an illusion. This is the same “self” that is discussed in all responsible religions, the “self” that separates us from the “Grace of God”; the experience of God.

    Looking at it in this manner, what is there to
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    dread? Nothing! And if we understand life from this perspective, we become unafraid. Instead of fighting life and attempting to puff up an ego that is non-existent, we can relax. We can live life fully as it sho
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    uld be lived, and no longer cower under a shadow of fear. This is the secret to life – and the secret to happiness as well.

    It begins with the simple act of sitting quietly, discovering what exactly our illusion
    .

    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
    s are, and then transcending them. Meditation or contemplative prayer is where we start, the beginning of a full life, a freedom that fears nothing; neither the end of the world, the end of the universe, nor the
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    end of our illusionary selves.

    There is something so much greater; it is all of us and we are all of it – a something that will survive the end of the world!

    Copyright © E. Raymond Rock 2007. All rights reserve


    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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