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    John and Cindy

    The new, bigger closet he was having built for her would finally allow them to spread out and organize their apparel. His golf shirts wouldn't be jammed together so tightly that the colors bled. Her skirts wouldn't be hidden between her dre
    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
    sses and her slacks, and both of them would be able to find their shoes. He'd get rid of the temporary studs-and-cedar plywood closet he'd built in the basement and bring her out-of-season clothes upstairs. He saw it as an opportunity to give their wardrob
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    e a breather.

    She, however, saw all this new, empty space as an opportunity to buy more clothes.

    ===============

    Vicki and Donald

    As an account executive in charge of a large budget, she was used to organization and was therefore taking a methodical ap
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    proach to planning their remodeling project. She researched costs, compared returns on investment for different kinds of additions, and even attended an evening course on house design. She measured their existing house and calculated exactly how much new 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
    pace they'd need. She charted the construction schedule and got pre-approved for the loan. She'd done everything but draw the plans but even then, she'd interviewed five architects before she made her selection. She knew he'd appreciate the careful, logica
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    l approach she'd taken and when everything was ready, she showed him the plans.

    "Wow" he said, "This bathroom plan is great! I'll be able to watch Sportscenter from the toilet!"

    ===============

    Rick and Fran

    There was no doubt about it. They'd outgrown
    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
    their house. Well maybe not outgrown, he thought. After all, it wasn't too small; it was just that the house and their lifestyle didn't really fit anymore. The children were nearly teenagers, and it seemed that the adults controlled less of the house ever
    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
    y day. They'd still be living together as a family for another seven or eight years and they needed a change. "It's time," he announced one evening at dinner, "to look for a new house!"

    And so the search began. He'd be in charge, of course, since the purc
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    hase of a new home is really an investment decision, one he'd make by evaluating cold, hard facts. "Most houses and neighborhoods are the same," he declared to his wife, "we're looking for value, school system, and proximity to work."

    Eventually he narrow
    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
    ed the choice to three candidates; a moderately-priced two-storey colonial with a large yard, but the kids would have to take the bus to school; a somewhat larger, more expensive home within a five-minute commute to his office; and an older home that neede
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    d a little work but in a highly desirable neighborhood.

    He arranged to show her all three homes on Saturday morning. It was a crisp autumn day and they enjoyed the drive around town. He could tell that she liked the first two homes and he began to contemp
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    late skipping the third. It wasn't a brand-new home after all, and he didn't think she'd be up for remodeling. Why go through all of that hassle and expense when the other two homes were in move-in condition? And so, secure in the knowledge that he'd chose
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    n the two best possible homes in town for his family, he turned the car left, away from house number three, and headed out of the neighborhood.

    About three houses down, a small handwritten sign with two yellow balloons attached to it caught her eye. "Open
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    House Today" it said, "1 to 4". "Look honey", she said, "there's a nice house". He slowed the car and took a quick look over his shoulder. He recognized the brick and stucco Tudor-styled house as 1245 Carnegie Street, a home suggested to him several weeks
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    earlier by a real estate agent. He'd glanced at the listing but dismissed it immediately. "It's too small and needs too much work" he'd told the agent "we're looking for something we can move into right away". "It has great curb appeal," the agent said "a
    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
    nd yes, it needs some TLC but it's priced well below market." "I'm sorry," he replied, "but it just doesn't meet our criteria."

    "Can we just stop and peek inside?" She was still looking at the two yellow balloons tied to the posterboard sign

    .

    "Honey,"
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    he said, trying not to sound patronizing, "I checked into that one a little while back; it's not a good fit for us."

    "But it's so cute!"

    Cute. He felt a slight tightening in his stomach. The last time he'd heard her use the C-word it ha
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    d cost him a new Boxster, when he'd been all set to sign the papers on a two-year old LeSabre.

    But wait a minute, he thought, there's no risk here. The house really is too small for us, and it does need a lot of work. Why not satisfy her
    .

    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
    curiosity?

    "OK," he said, "one quick look. But we have to hurry - we need to get an offer in on a house today."

    Five weeks later, he was showing friends the kitchen of their new home. It was a very nice kitchen, really, especially if you could imagine h
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ow it would look after the remodeling. New cabinets, countertops, and appliances, that's all. And then it would be brand new, as would the bedroom and bath they'd soon be adding onto the second floor.

    "Welcome," he said, "to 1245 Carnegie Street.


    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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