E-Articles - Health and Fitness

It is no secret that obesity in rising rapidly in many western countries and that the United State

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

s is leading the field but what is perhaps not so well known is that the number of those people cl

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

Examples of combination products may in

assed as severely or morbidly obese is growing at twice the rate of obesity in general.

Today mor

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

e than 30 percent of Americans are overweight with a body mass index (BMI) of between 25 and 29 an

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

another 30 percent are classed as obese with a BMI in excess 30. That means that more than 60 per

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

Combination pro

cent of the population of the United States is now classed as being either overweight or obese. Th

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

is is worrying enough in itself, but the underlying numbers show an even more worrying picture.

B

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

tween 2000 and 2005 the proportion of those people classed as being obese with a BMI of greater th

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

an 30 rose by just under 25 percent. However, the proportion of those classed as being severely or

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

morbidly obese rose by 50 percent in the same period and the proportion of those often referred t

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

as being 'super' obese with a BMI in excess of 50 rose by a staggering 75 percent.

At the same t

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

Following aspects would a

ime there has been an explosive growth in the number of bariatric surgeries being performed in the

dd to the challenges in developing combination products:

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

United States. In 1998 bariatric surgery was performed on about 13,000 patients and, by 2006, thi

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

s figure had risen to more than 200,000.

Today bariatric surgery is being performed in more and m

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

re hospitals and surgical centers and, in addition to tradition surgeries such as vertical or slee

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

ve gastrectomy and the Roux-en-Y gastric bypass, now encompasses a range of new techniques includi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng such operations as laparoscopic adjustable gastric banding and even robotic gastric surgery. Bu

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

, despite all of this, morbid obesity continues to rise and now appears to be virtually out of con

.

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

trol.

With the well know and often fatal health risks of such things as diabetes and heart diseas

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

Companies that provide selfless information through particip

e accompanying obesity one begins to wonder just what it is going to take to stem this rising tide

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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The debate on global warming, what is left of it, is often categorized as the far left versus business. Such a characterization is incorrect as shown by the US Climate Action Partnership.

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