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    Having had a busy week, I was only too happy to don my gardening clothes and get outside to do some planting,
    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
    weeding and pruning last weekend. “It’s interesting”, I thought, “how business refers to a slight improvemen
    ; 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 as the green shoots of recovery”. I then began to think of other gardening analogies that could be applied
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    to business. OK so now I’m being a bit sad and if I can’t just go outside and enjoy the air, maybe I should s
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    tay in more! But hang on, this can be a useful exercise. Think about it. If you “can’t see the wood for the t
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    rees” in your business but gardening is easier to relate to, then look at how you tackle your garden and how
    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
    you could apply the same principles to your business.

    First of all you need a plan of what you’re going to g
    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
    ow and where (Your business plan – what are you going to do and who is your target market). Maybe that plant
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    you put over in that shady corner is dying off so you may need to cut your losses and dig it up (that line of
    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
    business is losing money). The border flowers would do a lot better if there weren’t all of those weeds (too
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    many strands to the business) and every time you go to the shed to get your tools out there’s so much clutte
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    r you either can’t find what you’re looking for or it all falls out of the shed (desk clutter).

    Of course, o
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    nce you’ve done your planting, you’ll need to be vigilant about the watering otherwise nothing will grow, and
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    before you know where you are your annuals and shrubs will die off (marketing). Having said that, you will n
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ed to have time to sit back and observe your garden. It’s great watching your plants grow and it’s often when
    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
    you’re just enjoying that lazy hour that some new ideas will suddenly present themselves about how you could
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    make that border more interesting or build a rockery over there. (Time out to think and come up with creativ
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    e business ideas). And of course periodically you will have to do some heavy pruning and remove all the deadw
    .

    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
    ood (review the business procedures, are they still serving you well?).

    I guess there are many more comparis
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ons between gardening and business but I’ve got to go and inspect my new enterprise – the fruit and veg patch


    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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