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  • E-Articles - The Many Virtues of Infinite Measurability

    One of the major stumbling blocks in defeating childhood obesity is the lack of measurability, a way to conveniently evaluate progress, which results in a lack of motivation, and an epidemic that continues to grow like a forest fire raging out of
    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
    control.

    As a matter of fact the National Institute of Medicine recently (9/14/06) issued a disturbing report indicating that after spending over $68,000,000 over five years on just one program (there were many others), because of poor evaluati
    ; 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 methods, we still have no idea what works and what doesn’t work. We wasted $68,000,000…surprise, surprise.

    If You Can’t Measure It, How Do You Know
    But if you lack the ability to measure accurately how will you ever know if you’re
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    inning, losing, or just spinning your wheels? The State of Arkansas for example, is considered to be one of the nation’s leaders in the battle against childhood obesity. Bill Clinton has even gotten into the fray. They decided to measure every ch
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ld’s body mass index (the most commonly used indicator) and put it on their report card once every quarter…in other words, every nine weeks.

    How Do You Motivate Kids
    But even if this measurement is accurate and meaningful for kids, w
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ich is highly questionable in itself, getting feedback once every nine weeks packs almost no motivational punch at all. By the same token it’s economically impractical to measure on a daily, weekly, or even monthly basis. Once a quarter is about
    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
    he best they can do.

    Other more sophisticated measurement possibilities such as testing percentage of body fat via electronic impedance (computer) or underwater weighing are dramatically more expensive and much less likely to be used by anyone e
    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
    xcept a professor or grad student in a physiology lab. Furthermore, such models focus on the negative…how fat are you instead of how strong are you? Alack of regular feedback, in combination with their negative connotations DOOM the most conventi
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    nal strategies to failure. And after years of work, and multi millions spent, we still don’t know what works and what doesn’t work.

    Kindergartner Can Measure This
    In contrast, the documented measurability factor in a program called <
    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
    >Operation Pull Your Own Weight is extremely regular, and highly practical. You need no special instruments, no magic formulas, and almost no specialized training to tell if students are improving or not. If you can count from one to twelve,
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    s most kindergartners can, you qualify. As a matter of fact, elementary school age kids not only can, but they have measured themselves and others without problem. Not only that, but the strength gain focus of this program has very positive, not
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    egative connotations.

    The Feedback is Constant
    More specifically, OPYOW is based on the old coach's observation that kids who can do pull ups can't be obese. And kids who are obese can't do pull ups. The ability to do pull ups and ob
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    sity are mutually exclusive and where you find one, you'll not find the other.

    Now, using a height adjustable pull up bar and leg assisted pull ups, (the child’s encouraged to jump and pull at the same time) most kids can learn to do pull ups. T
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    e idea is to count and record (document change) the number of repetitions a participant can perform at a particular bar height. The program is initiated by finding a bar height at which a participant can do eight leg assisted pull ups which const
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    itutes workout # one. In workout # 2 they do nine, in workout # 3 they do ten, in workout # 4 they do eleven, and in workout # 5 they do twelve leg assisted pull ups. Then in workout # 6 the bar is raised one inch and the whole eight to twelve sc
    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
    nario begins all over again.

    The Motivation is High
    In other words each participant is taught how to improve regularly, in very small increments every week, every month, over a prescribed period of time. The progress is highly visibl
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    , highly motivating, INFINITELY MEASURABLE, and the positive feedback occurs every single time the participant works out.

    Under these conditions, along with public success and celebration (high fives), motivation remains high throughout the prog
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    am, evaluation becomes extremely easy and affordable, and the focus on strength gain instead of fat loss is positive not negative. In other words, Operation Pull Your Own Weight is extremely affordable, extremely motivating, and INFINITELY MEASUR
    .

    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
    BLE, DOCUMENTABLE, AND EVALUATEABLE.

    And In The End, You’ll Know
    At the end of a week, a month, a quarter, a year, you’ll know, unequivocally, if you’re winning the war, losing the war, or just treading water. You’ll never be in a po
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ition where you’ve just spent $68,000,000 and are still groping in the dark for answers. Not only that, but you’ll defeat childhood obesity naturally, without resorting to pills, shots, and special diets to get the job done. What more can you ask


    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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