E-Articles - Health and Fitness

Obesity has become a huge problem for most people living in developed countries. Today, 30% of children between the ages of 10 and 17 are obese and 60% of all adults are eit

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

her overweight or obese. There are many reasons for our overweight problem.

Obesity is responsible for increased rates of stroke, heart attack, type II diabetes, and even

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

Examples of combination products may in

ome forms of cancer. In fact it is responsible for as many premature deaths as smoking. Obesity has now become a threat to our longevity.

On the surface it would seem that

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

he underlying reason is really quite simple. If a person takes in more calories than the person burns, weight gain is the final outcome. These factors certainly play a rol

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

in obesity but there are more factors which contribute to this problem.

Modern society has changed a great deal from just a couple of generations ago when agriculture and

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

Combination pro

anual labor were common place. Today people spend a great deal of the day sitting at a desk in an office, driving the car, or relaxing on the sofa at home. All of which ha

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

affected the overall health of people living in developed countries.

By the time a person arrives home, the last thing most are thinking about is going for a walk or headi

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

ng off to the gym. Combine that with the idea that as a nation we eat just as much food, if not more than our ancestors did without nearly as much physical exertion and sudd

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

nly the recipe for obesity becomes very clear.

But there is more to it. Statistics show that we have actually doubled our food intake. This is where the fast food industry

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

is to blame. Everything has been super sized and not in a good way either with most of these foods being high in trans fatty acids (the bad fat) and sugar, it is easy to se

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

that weight gain is inevitable.

But the fast food industry cannot take all the credit. Our schooling system has allowed vending machines to offer children fast food and so

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

Following aspects would a

t drinks with provides no nutritional value and empty calories. School cafeterias that serve food are hardly a step above fast food. Add to that, most parents nowadays don

dd to the challenges in developing combination products:

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

t have time to cook traditional wholesome foods due their hectic work schedule and as a result buy convenience foods which are also high in fat and sugar and low in nutritio

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

.

As well both children and adults are now more sedentary than any other time in history. PE is no longer mandatory in schools; recess time has almost disappeared, after s

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

chool play time has been replaced with the Xbox or Gameboy. Now instead of the entire body getting a workout only the thumbs do.

Most adults are too busy or too tired to a

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

d an exercise regime to their day and even something as simple as a walk can seem demanding. The result is people do not have time to burn off all those excess calories tha

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

Professional from academic institutions, pharmaceutical industries, health care indust

they are consuming through the day.

Statistics show that if adults in the home are overweight then chances are that their children will also be overweight. Statistics hav

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

shown that when adults in the home are not physically active children in the home will not be active either. Studies have confirmed that both good and bad eating habits are

.

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

developed in the home. It is a combination of what adults allow their children to eat and what they serve their children which is contributing to our overweight crisis.

Th

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

Companies that provide selfless information through particip

reasons for our overweight problem are complex. Increasing physical activity and improving nutrition are great ways to start to work towards a solution to this predicament

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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