Advice Pool - Health and Fitness

Why is it that our country is suffering from an overweight and obesity problem? We have so many weight loss programs, diet programs, exe

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

rcise programs, available and money to pay for personal training. Yet, we are STILL OVERWEIGHT!

Below is a list of exercise programs th

; 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 the average individual might have heard of but don’t know what it is: Windsor Pilates, Bosu, Balance Ball, “Core” exercises. Fat Burni

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ng, Body Sculpting, Let’s mention the Diet plans available: South Beach Diet, Low Fat, Low Carbohydrate, Grapefruit Diet, and low white

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

arbohydrate Diet to name a few.

I was presenting at a national fitness conference and after the presentation, a younger personal traine

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

(mid-20’s) told me my presentation was very good, but I needed to delete the “old school” information. I didn’t get offended by it, but

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

I did reply by saying, “I would stop lecturing about the “old School” exercises, when I find something that will work!”

The problem wi

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

h this country is we don’t MOVE anymore. Our jobs keep us sedentary, for long hours, and then we get home and are too tired to workout.

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

People circle the parking lot like vultures so they can get the closest parking spot. Why not park farther away and walk?!

Now back to

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

he younger personal trainer. I explained to her that there are so many “Fad Diets and Fad Exercise programs” that people are forgetting

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

bout the most important criteria for weight loss. Movement – whether it be playing a sport, walking jogging, physical labor has all but

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

been eliminated from our society.

My (B squared) “Back to Basics” program focuses on exercises that all of us HAD to do in gym class. W

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

don’t like them because either we couldn’t do them or we could then but can’t now. I have developed a “Step by Step” approach to this p

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

roblem. When I have my clients exercise, they tell me they can’t do push-ups. So I start by having them hold in a starting position of a

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

push-up. Meaning they must hold themselves up from on the floor with their hands and feet. The body must be straight like a board. (Exce

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

lent "core" exercise) If you are working with a person who is unable to do that, which will be many, then they need to start with wall p

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

Professional from academic institutions, pharmaceutical industries, health care indust

ush-ups then decrease the angle as they progress. (Use the couch, chair etc...for a 45 degree angle)

If all of the musical groups from

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

he 70’s and 80’s are performing at sold out concerts (including Rolling Stones) one might think that the “New Generation” music isn’t as

.

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

good. In turn, we might rethink our Fad exercise programs, and Infomercial exercise equipment, Fad Diet Programs…and go back to the bas

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

cs. Back to movement exercises that do not assist you! Old style workout programs, and calisthenics. Let’s call it “Old School” workouts

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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Drugs and alcohol are directly related to domestic violence. Addicts often find themselves without their addiction. When this happens they can get very irritable, and many times abusive.

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