E-Articles - Health and Fitness

Nowadays, more and more Americans are obsessed with keeping their body weight down and shedding off some extra pounds. The introductio

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

n of fad diets and weight reduction programs is fast becoming an epidemic that is sweeping the country by storm. This is in response t

; 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 the disturbing percentage on the prevalence of obesity in the United States. Today, there are six out of ten American adults, approx

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

mately some 120 million, are struggling with serious weight problems according to the National Institutes of Health. This figure more

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

than doubled in numbers in comparison to the statistics a decade ago. And seemed to have put off a distress signal for Americans to be

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

Combination pro

more concerned with maintaining a healthy lifestyle and physique.

Obesity kills a staggering 300,000 Americans every single year and

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

health-care expenditures and associated cost of obesity have gone up to a whooping $ 100 billion per annum. The World Bank roughly est

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

imated that about 12 percent of the U.S. budget of health care is largely spent on the treatment of obesity. About $ 51.64 can be dire

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

tly attributed to direct cost of obesity such as the administered medical treatments. There is also an indirect cost of obesity in the

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

business sector, which is a result of higher absenteeism among extremely overweight employees, loss of productivity, and restricted a

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

tivity.

According to a recent study, the expensive cost of obesity does not only run up the health and a medical bill of overweight p

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

Following aspects would a

eople, but it is costing everyone as well. Some researchers estimated on year 2003 alone, every taxpayer pay around $170 annually whic

dd to the challenges in developing combination products:

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

h is mainly spent to manage obesity-related problems such as clogged arteries, cancer and diabetes.

The nation is undoubtedly forced

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

o pay too high a price for too many excess pounds with dollars, premature death and health complications brought about by obesity. Alt

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

hough there are a remarkable number of people who are consciously shifting to a healthier diet and lifestyle, there are still a great

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

umber who are unwilling or are incapable of reducing their calorie intake, eat better foods and exercise.

Government officials and he

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

Professional from academic institutions, pharmaceutical industries, health care indust

alth experts suggest that the only way to trim down the prevalence rate of obesity is to educate people and urge them to take full res

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

ponsibility of maintaining a healthy and fit body. The cost of obesity can be significantly curbed with making healthy choices and inc

.

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

easing physical activity. There are government- funded programs that are specifically designed to inform people about the grim facts a

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

Companies that provide selfless information through particip

nd consequences of obesity. But in the end, it is still the individual’s commitment to a healthier lifestyle that would count the most

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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