E-Articles - Health and Fitness

Eating too much can cause obesity - that is obvious. In addition, there are envir

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

onmental factors that might contribute towards a person becoming obese. Given the

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

Examples of combination products may in

typical American lifestyle, it is no wonder that so many people in our society s

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

uffer from this problem. The consumption of fast food, sedentary lifestyles, and

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

he common usage of cars rather than walking or bike riding all contribute to obes

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

Combination pro

ity. Sometimes a serious change of environment is needed in order to combat the p

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

roblem obesity.

Then there is the issue of metabolism. Back in the old days, we

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

sed to believe that weight gain and loss was equal to the number of calories inge

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

sted and burned, respectively. We now know that the case is not so simple. Resear

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

chers have recently come up with a theory that they call “the set point theory.”

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

n laymen’s terms, the idea is that there is a “set point” in the brain that can m

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

Following aspects would a

ake people resist either the gaining or loss of weight. If you exceed your brain’

dd to the challenges in developing combination products:

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

s set point by drastically cutting the number of calories you consume, your brain

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

’s response might be to slow down your body’s activities and lower your metabolis

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

. As a result of this process, any weight you might have lost is eventually gaine

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 back.

There has also been an increase in the average serving portions of food

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

Professional from academic institutions, pharmaceutical industries, health care indust

since the late 1970s. That increase has been especially prevalent in soft drinks

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

nd salty snack food. Other studies have established that people of today no longe

.

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

r stick to the recommended servings featured in the food pyramid of the USDA. By

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

Companies that provide selfless information through particip

having an unbalanced diet, people have a higher chance of becoming morbidly obese

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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