Your Space - Health and Fitness

This title of this article should really be "How A Chubby Army Ranger Got Lean Again." And I really hate t

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

o admit it, but that chubby (former) Army Ranger was me.

It's true. Here's how it happened. Six months a

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

o I woke up one morning and wandered over to the bathroom scales that had been collecting dust for about a

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

ear. I was totally shocked when I stood on those scales and peered down over my protruding belly.

See, as

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

a former Army Ranger I've always paid close attention to my weight and staying at least somewhat in shape.

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

Combination pro

Of course I had noticed my pants were a little tighter, but just couldn't believe my eyes when I looked at

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

those scales and was 20 pounds over my normal weight. 20 pounds in a year! I learned a lot of creative cu

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

rse words in the Army and I'm pretty sure I used every one of them that morning.

About that time my busine

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

s partner introduced me to a cleansing and nutrition program from Isagenix. He had started the Isagenix 30

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

day Program two months earlier and had already lost 40 pounds. No kidding, 40 pounds in two months!

So I

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

ecided to give it a try and the results were fantastic. I tried the Isagenix 9-Day Program and in 9 shor

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

Following aspects would a

t days, I shed 12 pounds of fat and lost 8 more pounds over the course of a month. In 30 days I was back d

dd to the challenges in developing combination products:

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

wn to fighting weight.

And here's a confession for you. I didn't work out at all...not one single time!

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

'm not proud of that. I just didn't do it for whatever lame reasons. I can only imagine what amazing re

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

sults I would have seen if I would have exercised even a little bit that first month.

So here I am six mon

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

hs later. I've dropped 25 pounds and weigh less than I did when I was in college (I'm 38 now). I sleep be

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

Professional from academic institutions, pharmaceutical industries, health care indust

ter at night, I have an abundance of energy to chase after my 4-year-old daughter and 2-year-old son (I nee

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

d it!), my blood pressure is finally normal, and I feel better than I have in years.

Does Isagenix work?

.

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

t absolutely does. Can Isagenix work for you? Absolutely it can. I've introduced Isagenix to countless f

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

Companies that provide selfless information through particip

iends and family and all of them have experienced some or all of the same benefits I have. And you can too

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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