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  • Useful Advices - Choose Your Favorite (Model): 1,2, 3, 4, 5, 6, 7, 8 or 9

    Counting starts at one. It is a perfect starting position to start the most popular game on the internet; dating, you need as much as yourself.
    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
    That is, if you are a single and looking for a date.

    With two, just having met a date, most (real) problems start. Most games start with two (p
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    layers). We all know about the universal dichotomies of black and white, left and right, right and wrong. The number two provides a very simple
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    (and therefore) powerful system to categorize … differences.

    Three is also used to model the real world, for example by Treacy and Wiersema, kn
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    own for their “value disciplines” which are: operational excellence (1), product leadership (2), or customer intimacy (3).

    Four is used quite o
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ften in models. The Myers-Briggs Type Indicator for example results in an overview of sixteen types, but four (dominant) types form the core of
    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
    the model.

    The five-factor model is comprised of five personality dimensions (OCEAN): Openness to Experience, Conscientiousness, Extraversion,
    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
    Agreeableness, and Neuroticism.

    Six is also possible, but relatively seldom. The thinking hats of De Bono (white, red, black, green, yellow and
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    blue) or recently the six values (gold, silver, steel, wood, copper and glass) is a good example.

    Seven is abundantly available. The seven hab
    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
    its of highly effective people (S. Covey) for one. But think also about the top7 lists that fill the internet everywhere. Seven appears to be a
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    agic number. But scarcely used in models.

    Eight. Belbin, for example, uses the number eight to present different team roles; the Implementer, S
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    haper, Investigator, Plant, Team worker, Coordinator, Monitor and the Completer (The ninth role, the specialist is left out because it was added
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    later) In fact the basis for the Belbin team role concept consist again of only four main characteristics (thinking, doing, feeling and willing
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    )

    Nine – The Enneagram uses nine types; The Perfectionist, The Giver, The Performer, The Romantic, The Observer, The Loyal Skeptic, The Epicure
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    , The Protector and the Mediator.

    Selecting a preference is not about the merits of each individual model. You should choose one that fits a re
    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
    al requirement or you might stick to using one you already are familiar with and if it serves your goal.

    My own preference is to use models tha
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    t apply less than seven types. Seven may be a magical number, but will make models complex. It is said that seven is the maximum number of items
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    your are able to memorize on the short term, a fact that contributes to this complexity. One, on the other end, is not an option either -- thi
    .

    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 would result in a model describing everything. Two is for children to distinguish only between good and evil. So a real model start with at le
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ast three options. And between three and six, I intuitively go for an even number with the least number of possibilities. Four.

    © 2006 Hans Boo


    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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