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    As a frequent traveler, my goal for each trip is to travel light. Despite thoughtful planning, sometimes that goal is shattered when I go to c
    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
    lose the suitcase and realize I need a larger, or even second one. I can't always get my packing right and end up taking more than I need. Whe
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    n that happens it's frustrating. I hate lugging extra baggage and feeling encumbered.

    Work is like that, too. We often bring too much baggage
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    . It may not look like baggage, but it weighs us down just the same. It's disguised as past relationships with bosses; previous work experienc
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    es; mind-talk about whether we can or can't do something; how we've been treated in work (and life), or how we think we have. And usually ther
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    e's at least one duffle bag stuffed with our expectations.

    I've found in twenty years of management most people bring suitcases full of self-
    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
    doubt, old patterning from old relationships and self-fulfilling prophesies to work every day, and it stifles them. Most people let past work
    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
    experiences dictate their future ones. So if they've worked in three different jobs or companies, those three job experiences are packed into
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    the suitcases they're lugging. Some people end up lugging dozens and dozens of them.

    They're like the travelers in this story I heard. One da
    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
    y a young man stopped his car at the side of the road as he entered the township limits. An older woman paused from her gardening as he approa
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ched. "I'm thinking of moving to this town," he told her, "and I was wondered if you could tell me what the people are like here?" "Well," she
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    said, "what were the people like where you lived before?" "Demanding and competitive and not very helpful," he said. "Well," she told him, "I
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    think you'll find people the same way here."

    A little while later another man stopped and approached the woman. Again she was asked what the
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    townspeople were like and again she asked the traveler what his experience had been where he lived before. "Oh, the people were great. Everyo
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ne was helpful and supportive – a real community." "You'll find people the same way here," she said.

    People who are winning at working are li
    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
    ke that second traveler. They know in work (and life) you tend to get what you expect. And if they're encumbered with emotional baggage and p
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    oor expectations, they get poor results. Instead, they follow advice like Deepak Chopra's, "Always expect the best and you'll see that the out
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    come is spontaneously contained in the expectation."

    People who are winning at working are one suitcase people. Like a seasoned world travele
    .

    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
    r, they've learned what essentials to pack. They bring to work only those skills and experiences that will positively impact their work and fu
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ture. They leave the rest of their baggage behind. Want to be winning at working? Travel light.

    (c) 2005 Nan S. Russell. All rights reserved


    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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