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    The Traditional Purchase

    Traditionally, a purchase of a costly article is financed through a loan. Let us consider car
    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
    s for our comparison. So, to purchase a car, if we don’t have the lump sum to place on the dealer’s desk, we must have the amou
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    t financed. Now, we reach the point when we are confronted with a traditional car loan and the process of leasing.

    As we all k
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ow, a car loan will have an interest rate and a payback term that will give us equal payments which are easy to make. As an exa
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ple, let us say that a vehicle worth $20,000 can be purchased with a 36 month period and an interest rate of 7.7% which gives a
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    monthly payment of around $624.

    Now Let Us Compare It To A Lease

    A typical lease is a kind of rent with the option t
    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
    own later, in some cases, depending on the agreement and the leasing party. It involves lower monthly payments than a normal l
    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
    an and the reason is that you are paying only for the portion of the vehicle that you use.

    The 3-year value of the same car wo
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    th $20,000 will be around $8,000 to be paid during the three years, plus an interest or a fee for that term. The remaining valu
    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
    e of the car is $12,000, which you do not have to pay if you return the car or you change it for a more recent model, in which
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ase you continue to pay the low installments. If you are given the option to buy, you still have the remaining $12,000 to pay,
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    eaning a much longer term.

    The Comparison

    If you purchase directly, you will pay approximately the whole price of the
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    car in the same three years mentioned and you will be the sole owner of the vehicle and you may do whatever you wish with it. T
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    he upside of a lease is that you have the option to continue leasi
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    g a brand new model, keeping your leased vehicle within an age of not more than three years at all times.

    Another Differenc
    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


    In both cases there is a down payment to be made. For a lease it can be as low as $1,000 whereas for a purchase, you wou
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    d have to disemburse between 15% and 20%, which, for a car worth $30,000, means between $4,500 and $6,000, certainly an importa
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    nt sum.

    Additional Cost

    There is an additional cost if you surpass the amount of miles stipulated in the agreement yo
    .

    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
    sign, which is paid at the end of the lease. The only dilemma is the choice between owning the car and just renting it. If you
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    travel a lot, work out the difference between the excess mileage you have to pay and the higher cost of purchasing the same car


    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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