E-Articles - Health and Fitness

Obesity has been growing rapidly in the adult population of many western nations for some years now and is official

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

ly at epidemic proportions. This is worrying enough in itself, but of much more concern perhaps should be the incre

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

Examples of combination products may in

asing incidence of obesity in adolescents and even younger children. In the United States today obesity is seen in

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

more than 15 percent of teenagers and this figure is rising steadily.

So just what are the risks from obese teenag

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

ers?

The risks in teenagers are very much the same as those seen in adults and include sleep apnea, high blood pre

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

Combination pro

ssure and the development of coronary diseases amongst other things. However, most importantly, obesity in your tee

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

nage years can actually lead to your premature death.

In 1989 the National Institute for Health funded a study des

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

igned to follow the health of a large group of young women over an extended period and to look, amongst other thing

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

s, at diet and lifestyle risks. More than 100,000 women (employed as nurses across the United States in states incl

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

uding California, Iowa, Kentucky, Michigan, New York, Pennsylvania, South Carolina, Texas and others) between the a

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

es of 24 and 44 were enrolled into the study.

All of those taking part in the study completed a comprehensive ques

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

Following aspects would a

tionnaire at the outset, which included details of their medical history and such things as their weight during the

dd to the challenges in developing combination products:

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

ir teenage years, and were then closely monitored over a 12 year period.

During the period of the study a total of

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

710 of the participant died and when the researchers studied these deaths they discovered that there was a connect

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

ion between obesity in these women in their teenage years and premature death. Indeed, the study showed that women

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

who were obese as teenagers were at three times more risk of premature death than those of normal weight.

Today a

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

Professional from academic institutions, pharmaceutical industries, health care indust

great deal of attention is being focused upon finding a solution to the growing problem of obesity and this is quit

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

e rightly creating considerable research into the problem itself. As each day passes we are beginning to understand

.

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

the risks of obesity more and more and the figures being produced by a whole range of studies make quite frighteni

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

Companies that provide selfless information through particip

ng reading.

Let us hope that it is not too long before we find a solution and reverse this rising trend in obesity

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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