E-Articles - Health and Fitness

How do we define obesity? In simple terms, it can be viewed as the excessive accumulation of body fat. When boys possess more than 25% fat in their tota

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

l body weight, and girls possess more than 32%, then they are considered to be obese. Adults have a variety of medications they can rely on to combat ob

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

Examples of combination products may in

sity. These include Apidex and Phentermine. It’s a different story, however, for children.

Obese children are at risk for developing a variety of illne

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

ses and diseases. They are at risk for developing pediatric hypertension, for example. This disorder increases the risk of contracting type 2 diabetes,

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

roblems with the joints, as well as cardiac disease. What can be a worse – and more immediate – problem for children dealing with obesity is the social

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

Combination pro

tigmatization they often become the victims of, which results in serious emotional and psychological problems associated with low self esteem. Obese chi

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

dren often grapple with depression – much more so than non obese children. But just because one is obese as a child does not necessarily mean they will

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

row in to an obese adult. There are all kinds of factors that determine obesity, including genetics and hereditary factors. If the problem is dealt with

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

from an early age, adulthood obesity can be avoided.

But let’s focus on one of the less obvious aspects of childhood obesity for a minute. While the ca

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

ses of obesity are well reported – namely lack of exercise and bad eating habits – there are also familial and hereditary instances of obesity that are

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

ess often analyzed. Children whose parents are obese have a much greater chance of becoming obese themselves. Perhaps this has to do with genetic factor

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

Following aspects would a

s, but more often than not, it has to do with the family’s sedentary lifestyle and eating habits. If parents do not take proper care of themselves, then

dd to the challenges in developing combination products:

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

their children can be born obese.

It is also true that not all children who lead the sedentary lifestyle so common of young people today – that is spen

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

ing more time in front of the television and computer than outside playing sports and being active – wind up becoming obese. Researchers have been looki

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

g in to the reasons why this is so. It probably has more to do with heredity than anything else. Heredity can influence such factors as one’s response t

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

overfeeding, one’s degree of fatness, as well as the way fat is distributed in one’s body. Recent studies have also established that babies born to ove

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

Professional from academic institutions, pharmaceutical industries, health care indust

weight mothers tend to be less active and gain more weight in early infancy due to some apparently internal desire to conserve energy.

Children who are

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

overweight and lead inactive lives, spending excessive amounts of time engaged in non physical activities such as playing video and computer games and w

.

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

tching television, certainly will not combat obesity in this fashion. Parents should do everything they can to discourage this “couch potato” lifestyle,

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

Companies that provide selfless information through particip

while also monitoring their children’s eating habits. A healthy home life makes for healthy children, who are more likely to develop into healthy adults

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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