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    Back “in the day” when I used to be a full time personal trainer and I met with clients in person at my New Jersey Health Club, the first thing I would always ask my clients during the initial consultation was:

    "Tell me exactly what you want... and I'll show you how to get it."

    Typical reply from client:

    "I want to lose 20 pounds fast."

    My reply:

    "Are you SURE that's what you want? If I can show you how to lose 20 pounds REALLY, REALLY fast, will tha
    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
    t make you happy?"

    They nodded their head affirmatively as their eyes lit up in anticipation of the quick weight loss secrets I was about to reveal...

    Their face went white when - with a totally straight face – I pulled out a hacksaw and started walking towards them.... menacingly.

    Not sure whether to laugh or to run away in sheer terror, they said,

    "What the heck are you doing?"

    "You said you wanted to lose 20 pounds fast. This is the easiest, sures
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    , most effective way I know to take 20 pounds off you FAST! In fact, I figure that right leg of yours might even weigh 25 pounds!"

    I kept walking closer and started to get into sawing position, wielding my fast, effective and guaranteed weight loss tool...

    "Bear with me because this IS quick, but sometimes it takes a few minutes for me to cut through the bone."

    By this time, my client and I are either completely cracking up, or I have seriously scared
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    he living you know what out of them, or they just think I'm a complete lunatic... (it depends on whether I was able to keep a straight face or not).

    Finally, the light bulb goes on, and my client would see where I was going with this:

    "Okay, smart alec," I get it... I don't want to lose WEIGHT, I want to lose FAT."

    Sometimes I would be having so much fun, I would just keep on playin'...

    "But why not? This is easy, fast and guaranteed - just what every
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ne wants these days... it's even better than taking a pill! Come on... let me hack it off! You'll be my next testimonial: 'I lost 20 pounds in 5 minutes!' Imagine what that will do for my business!"

    "Very funny. I told you, I get it, I get it! I want to lose FAT, not muscles and bones. I need my leg!

    Naturally, of course, I didn’t always have to pull out my trusty blade. Every once in a while... about as often as a total solar eclipse... a client answer
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    my question like this:

    "What do I want? Tom, I want to lose 20 pounds of body fat in the next 12 weeks. I want to do it slowly, safely and healthfully and then keep it off permanently. I want all the fat around my hips and thighs completely gone and I want a firm flat stomach. I want muscle all over my body while still looking feminine. I'd like to see myself at about 16% body fat and maintain all my muscle or gain a few pounds of lean mass if I can, es
    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
    ecially in my arms. This is important to me because I want to set a good example for my kids, I want to be healthy and live to at least 90 and I want my husband to look at me and say, "I love your body, honey," and I want to be able to *honestly* say back to him, "me too!"

    It is on these rare occasions that I know there is still intelligent life on this planet.

    If you could answer the question, "What do you want" with the degree of clarity that this wom
    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
    n did, I don't think you would ever have any difficulty reaching your health and fitness goals... or any other goal in your life, for that matter.

    This answer is what you call a very "well-formed" goal, backed up with lots of emotional motivation-inducing "reasons why."

    "I want to lose weight" is a poorly-formed goal.

    "Weight" is not the same as "fat." Weight includes muscle, bone, internal organs as well as lots and lots of water.

    If you only get ONE
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    thing from this article, get this:

    WHAT YOU REALLY WANT IS TO BURN THE FAT, WHILE KEEPING THE MUSCLE!!!!

    FAT LOSS is what you want, not weight loss.

    If your body was 100% rock-solid muscle, with absolutely nothing that jiggled (unless it was supposed to), would you care how much you weighed?

    I bet you wouldn't!

    SO STOP WORSHIPPING THE SCALE AND START MEASURING YOUR BODY COMPOSITION!

    By measuring your body fat, you take the guesswork out of your heal
    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
    h and fitness plan and you get an accurate picture of what's really happening in your body as a result of your diet and exercise program.

    Instead of worrying about whether you are losing muscle, or wondering if you are losing fat, you can measure it and KNOW for sure. (I always get a good chuckle when someone tells me they're worried about losing muscle when they don't even measure how much muscle they have!)

    Instead of being confused by all the "opinio
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    s" from weight loss and exercise "experts" who are all telling you something different, you can MEASURE your body composition and based on the results, you can KNOW for sure whether your program is working.

    A very wise man once said,

    "A single measurement is worth a thousand opinions."

    So, how do you measure body fat?

    There are many methods. Thanks to technology, there are some methods today that are so accurate, they can tell you whether your left pi
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    nky has more fat than your right pinky! Unfortunately, many of them are either too expensive or they are inaccessible, being found only in hospitals or research facilities.

    Instead of boring you with a lecture about all the various body fat testing methods, let me give you three quick and easy, practical suggestions:

    Suggestion 1: Have a trainer or fitness professional measure your body fat if this service is available at your local health club. Sometim
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    s, there's a charge - usually $15 - $25, although some clubs offer the service for free to all their members.

    Suggestion 2: Purchase an Accu-measure skinfold caliper. The Accumeasure was designed to allow you to measure your own body fat in the privacy of your own home (you don't need someone else to measure you). Do a google or yahoo search to find a reseller.

    Some people wonder if this is really accurate. Truth is, it's not quite as accurate as a mult
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    site skinfold test from an experienced tester, but it's better than nothing. Besides, what's most important is not the "accuracy" per se, but the reliability and consistency of your measurements so you can track your progress. Skinfold calipers in general are not accurate or inaccurate, it's the person doing the test that is accurate or inaccurate.

    Suggestion 3: If you have a spouse, roommate, or friend who can measure your body fat, you can purchase a
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    Slim Guide” body fat caliper. The Slimguide is the best inexpensive (about $20), caliper available for multi-site testing, but it wasn't designed for you to measure your own body fat like the Accu Measure. Other models of body fat calipers (if you want to splurge), range from $150 to $450. (At our health clubs, I use the electronic "SKYNDEX" caliper with the 4-site "Durnin formula.")

    The calipers come with instructions, or you can use these formulas, whi
    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
    h I have used and found to be very accurate:

    4 Site formula for men (abdomen, suprailiac, thigh, tricep)

    % fat = .29288(sum of 4 skinfolds) - 0.0005(sum of four skinfolds squared) + 0.15845(age) - 5.76377

    4-Site Formula for women (abdomen, suprailiac, thigh, tricep)

    % Fat = (.29669)(sum of 4 skinfolds) - (.00043)(Sum of four skinfolds squared) + .02963(age) + 1.4072

    Source: Jackson A S, Pollock, M (1985) Practical assessment of body composition. Phys
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    cian Sport Med. 13: 76-90.

    Body fat percentages vary based on age and gender, but 20-25% body fat is average for women (15-19% is ideal), while 15-20% is average for men (10-14% is ideal).

    Once you know your body fat percentage, then weigh yourself and record your weight and body fat on a progress chart. You can also calculate your lean body mass (muscle and other fat free tissue) very easily just by crunching some numbers:

    For example, if you weigh 20
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    pounds and you have 10% body fat then you have 20 pounds of fat (10% of 200 = 20). That means you have a lean body mass (LBM) of 180 pounds. Now we're talking! With this data, you can get a really clear picture of how your exercise and nutrition program are affecting your physique.

    Losing weight is very easy. Losing fat - and keeping it off without losing muscle - is a much bigger challenge. If you simply wanted to lose weight, we could just chop off yo
    .

    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 leg. Or, (slightly less painful), I could show you how to drop 10 - 15 pounds over the weekend just by dehydrating yourself and using natural herbal diuretics. Bodybuilders and wrestlers do it all the time to make a weight class. But what good would that do if it’s almost all water and you’re just going to gain it all back within days?

    You don't have to "throw away your scale" like many "experts" tell you to. By all means, keep using the scale, the tap
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    measure and even photographs and the mirror - the more feedback the better, but body fat is where it's at.

    By the way, I recently bought a chain saw and a shiny new axe from Home Depot, and I've been practicing my "American Psycho" and Jack Nicholson, "The Shining" impersonations... so if you want to come to my office any time soon for personal consultation, you'd better have the right answer to my question, "What do you want?"

    Copyright 2005 Tom Venut


    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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