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    The Photograph

    The little girl is scared. This place is new. Different. Bright. Hot. She wonders, “why is this strange man is talking to me?” He raises his voice. “Look over here,” he hollers. She’d look but the lights are bright. He holds up a toy
    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
    . He squeezes it. The toy’s eyes pop. It’s interesting. Fun. She smiles. A bright flash of light pops. Her mother says, “Good girl!” They are done. The picture has been created.

    Someday the girl will appreciate this photo. She’ll marvel at it. Scrapbook i
    ; 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. Show it off. Her kids will marvel. Laugh. Enjoy it too. So will their kids. But on this day she was afraid. The situation was new. Unknown. She wouldn’t have looked if not for the toy. It caught her attention. Its fun beckoned. And the light went
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    on.

    This scene repeats itself millions of times a day at Wal-Marts, Olan Mills, Sears, photography studios all over the world, and in classrooms filled with adults afraid of learning.

    Survival or Pleasure

    Our brain has a dual focus, survival
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    and pleasure. Survival is the baseline. Without survival nothing matters. Our brain, to insure survival, never stops looking for threats. All the components of the brain, even those responsible for logic and arts, refocus immediately if the brain per
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ceives a threat. This dynamic cannot be ignored in the classroom. Ideas, and the intellectual application of those ideas, are unimportant to a threat focused brain.

    Once a brain determines that survival is temporarily secure, it refocuses on the sec
    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
    ond priority, pleasure. The brain doesn’t specifically want to have fun. It’s just that many pleasurable sensations, including sleep, eating, sex and play, are directly tied to survival. The survival connection to food, rest and procreation seem obviou
    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
    s. The brain also needs intellectual stimulation. Thinking is the brain’s own exercise machine, keeping it healthy, alert and functioning.

    Being Right Or Being Left

    A large portion of our brain, our neocortex, consists of a left and a right
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    hemisphere. The corpus callosum provides a communications bridge between the two halves. And the two hemispheres need all the communication help they can get. They see very little the same way. They resemble two siblings whose experience is the same
    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
    but who rarely agree about what they experienced. With the help of the corpus callosum, the two hemispheres are able to partner. Together they simultaneously comprehend the details and the context.

    Generally, the left hemisphere thinks logically, the
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    right holistically. The left sequentially: the right randomly. The left analyzes, the right synthesizes. The left comprehends words: the right comprehends metaphors. The left examines what is said: the right discerns how it is said. The left seeks fa
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    cts and details: the right stories and visuals. And most importantly for this discussion, the left processes positive emotions like laughter and joy: the right processes negative emotions like fear and disgust.

    This duality allows our brain to size
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    up unknown situations quickly. The right hemisphere surveys the big picture looks for survival threats. The left hemisphere analyzes the potential threats, and if no threat is present, looks for the positive aspects of the situation.

    When the incomi
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ng information doesn’t fit recognizable patterns, our brain goes on alert. If the right perceives negative potential it directs the release of cortisol. If the left perceives positive potential, adrenaline is released. Both of these brain chemicals s
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ear memories into our brain. They allow us to remember the events years afterwards.

    Baby-Sitting Adults

    The threat of threats doesn’t disappear in adults. As a result, the brain’s survival focus can block learning. To the wary brain, a classro
    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
    om can be Uncomfortable. Foreign. Threatening. The act of learning implies a lack of completeness. Learners suspicious of facilitator motives, or fearful of their own learning disabilities, can become so wrapped up in right hemispheric negativity tha
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    t they switch into survival mode. Learning is forgotten. Given that this brain panic cannot be stopped, smart trainers find ways to harmonize with and direct the brain’s dual focus.

    That’s where Learnertainment® comes in. Entertainment style activitie
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    s baby-sit the right hemisphere, keeping it busy with things it likes; cartoons, music, games, interactivity, mnemonics. These activities provide the pessimistic right with a positive context. Once the right hemisphere is playfully engaged, learning
    .

    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
    can commence without blocking.

    If you want your trainees to “look at the camera,” baby-sit them. Focus them on pleasure. Not survival. Tell a joke. Display a toy. Play some music. Make it fun. By doing so, you will help snap mental pictures they can
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    savor years into the future.

    Visit Lenn on line at www.offbeattraining.com. Blog with Lenn at http://offbeat-online.blogspot.com


    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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