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    “Our mind is capable of passing beyond the dividing line we have drawn for it. Beyond the pairs of opposites of which the world consists, new insights begin.” --Herman Hesse

    Doorways, portals, gates and thresholds have served throughout history as the potent objects and symbols of superstition, rites and rituals (1), psychologi
    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
    cal development, and transcendent religious experience.

    We commonly refer to windows of opportunity, doorways to the future, and open-door policies. Some say we must open a door at midnight to allow evil spirits to depart and that the first person to open the door on Christmas morning will have good luck. It’s bad luck, some be
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    lieve, to leave a house by a different door than the one used to enter the house or to eat in front of a door.

    Brides, writes Tad Tuleja, are not carried over the threshold because they’re incapable of walking into a house or because the groom is simply being a gentleman, but “because, as a stranger, she was taboo. It was only
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    after she had actually entered the room—after she had, in effect, been sneaked past the guard—that the contagion of taboo was considered lifted.” (2)

    Important thresholds in both psychology and transcendent mythology typically have guardians. You will see these symbolized by the lions, dragons, gargoyles, fu dogs, and other bea
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    sts at the main entrances of churches, libraries, and other buildings. Beliefs vary about the origin of portal or threshold guardians. Some say they are a projection of our own fears, while others say that the guardians are placed there by the gods.

    Hero myths, and the threshold guardians involved, impact us on multiple levels.
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    Stemming from the work of Otto Rank (3) and others who studied the heropath and its connections to the first stage of life, myths are viewed as a symbolic of the dramas experienced by an individual as s/he comes to terms with parental authority figures and manages a healthy emergence out of the family nest as an autonomous adul
    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
    t. Stephen Larsen writes:

    “As the child ego seeks to find independence from the all-nurturing, yet all-embracing, realm of the mother, a great inner struggle must be mobilized. The dragon to be slain by the hero is the instinctive bondage to smothering mothering, especially after the child needs less nurturing and more freedom
    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
    to encounter its own destiny. The aggressive attitude necessary to acquire autonomy is appropriate to the first part of the hero journey, but this is the point beyond which—unfortunately—the na?ve interpretation fails to go.” (4)

    The complete interpretation, in fact, not only considers an individual’s adult life but also includ
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    es the continuing inner journey to the psyche’s greatest depths. Mystery schools and some fraternal organizations ritualize this continuing journey through a series of thresholds and initiations. Mystics often refer to a series of gates indicating levels of transcendence. Myths dramatize the stages of the deeper journey through
    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
    multiple threshold experiences.

    When Jason, for example, accepted King Pelias’ challenge to seek the Golden Fleece, he made a commitment that can be considered the crossing of a threshold. Subsequently, Jason and his shipmates, including Hercules, Theseus, Orpheus and Nestor set sail aboard the Argo. Ultimately, they found thei
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    r passage into the Euxine Sea (Black Sea) blocked by two floating islands that crashed back and forth on the waves. These clashing rocks were called the Symplegades at the Hellespont (Dardanelles) between Europe and Asia. Heeding the advice of a wise man, the Argonauts safely followed a dove through the treacherous strait, after
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    which Zeus anchored the rocky islands forever. This myth illustrates an important threshold on the hero’s path.

    The hero, like all of us, comes from a world of duality, one dominated by pairs of opposites: good/bad, dark/light, mine/yours, us/them, pleasurable/painful. These opposites are said to clash with each other obscurin
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    g the fact that opposites in each pair are the two sides of a single coin. That is—depending on your frame of reference—they are all God’s thoughts, nous, spirit, the force, or manifested energy and not the polarities they appear to be. When Jason sailed past the Symplegades the clashing stopped, symbolizing what the hero or see
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ker finally “sees” when s/he steps out of the world of opposites. As Joseph Campbell (5) sees it:

    “One can have an intuition that is beyond good and evil, that goes beyond pairs of opposites—that’s the opening of this gateway into this mystery. But it’s just one of those little intuitive flashes, because the conscious mind come
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    s back again and closes the door. The idea in the hero adventure is to walk bodily through the door into the world where the dualistic rules don’t apply.”

    Or, as Rama C. Coomaraswamy puts it in his introduction to “Guardians of the Sundoor:”

    “What could be more common than a doorway? To quote Gray Henry: ‘It is more than coinc
    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
    idental that many doorways throughout the world exhibit a corresponding set of symbolic motifs that point to the One manifesting itself as duality – a duality and a world that must return to that One.’ One must pass through the duality of the doorjambs to the unity which is only to be found in the centre. As Christ said, ‘I am t
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    he door,’ and ‘No one comes to the Father but through Me.’ The passage through the door is always a passage that at least symbolically involves a change of state…”

    Doorways inhabit our lives offering hope, expanded communications, initiations into mysteries, new lives, and a glimpse at—or even a merging with—the Creator. Mythic
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    stories of the heropath at their deepest and most profound levels speak to old archetypes that we all know at the deepest levels of our minds and provide a means through which we can perceive the route ahead.

    NOTES:

    (1) See, for example, Van Gennep, Arnold, “The Rites of Passage,” Chicago, University of Chicago Press, 1960.

    .

    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
    (2) Tuleja, Tad, “Curious Customs,” New York, Harmony Books, 1987.

    (3) Rank, Otto, “The Myth of the Birth of the Hero,” in “In Quest of the Hero,” Princeton, New Jersey, Princeton University Press, 1990.

    (4) Larsen, Stephen, “The Mythic Imagination – The Quest for Meaning Through Personal Mythology,” Rochester Vermont, Inner T
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    raditions International, 1990, 1996.

    (5) Campbell, Joseph, “Pathways to Bliss,” (David Kudler, ed.), Novato, California, New World Library, 2004.

    (6) Coomaraswamy, Rama C., in Coomaraswamy, Ananda, K., “Guardians of the Sundoor – Late Iconographic Essays and Drawings” (Robert Strom, ed.) Louisville, Kentucky, Fons Vitae, 2004.


    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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