E-Articles - Health and Fitness

The nutritional requirements of a child have to be considered carefully. Growing children require a high amount of energy intake to help them to grow, but, just as with adults, if energy intake exceeds energy usage, the child will put on we

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

ight.

Naturally, children should, and must, gain weight through the natural process of growth, but many children go beyond that and put on excess fatty tissue; i.e. they become obese. Obesity is rapidly becoming a serious problem with toda

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

Examples of combination products may in

’s children, partially through the wrong nutrition and eating too much of the wrong foods, and partially through ignorance on behalf of the parents who have a misconception that ‘puppy fat’ is a healthy and normal thing.

To a certain extent

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

this is true, but excess ’puppy fat’ is as dangerous to a child as excess fat is to an adult. It is estimated that more than 15% of UK children are overweight or obese, and this figure is rising rapidly. The Journal of the American Medical

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

Association reported on the 4th April that the level of overweight American children was 33.6%. Obese children grow into obese adults. They do not lose this so called ‘puppy fat’ unless positive steps are taken. They have a significantly

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

Combination pro

igher risk of developing serious health problems , both now and as an adult, including potentially life threatening conditions such as bowel cancer, diabetes, strokes, heart conditions and high blood pressure. The more overweight the child,

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

the greater the risk.

There are also psychological problems to consider. Overweight and obese children frequently experience playground teasing about their appearance which can destroy self esteem and confidence, and lead to isolation and d

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

epression. This can last for the rest of their lives, and often leads to such children taking up smoking and drinking alcohol at an early age.

It is predicted by health experts that due to our children’s poor diet and lack of exercise thei

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

own parents will be outliving them. This is a scary thought, is it not. The most exercise many children get is getting out of bed! Many spend their leisure time in front of a computer or games console. School sports are non existent in

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

any schools due the ethos of everyone having to be a winner. Competition in sports is bad because someone must lose. Many school playing fields have been sold off by local councils to developers. How short sighted!

It is very rare for ch

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

ldren to be overweight due to health problems. The opposite is true. Children have health problems because they are overweight. Unless diagnosed by a doctor, health problems should not be used by parents as an excuse. Similarly with geneti

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

Following aspects would a

cs. Although genetics can play a part, it is only a very small part. Fat parents frequently have fat children, but this is not usually genetic. How about the fact that children mimic the bad eating habits and activity habits of their pare

dd to the challenges in developing combination products:

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

ts? How often have you seen parents and children living off Big Macs and other fatty convenience foods.

Rather than blame obesity on genetics or health problems parents should look at their child’s unhealthy lifestyle. Their lack of exerci

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

e and physical activity. It is become easier for children to become overweight. Sweets, convenience meals, fast foods, all full of excess salt and sugar. They are targeted at children through TV advertising. Have you ever sat and watched

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

TV with your child on a Saturday morning and taken note of the adverts? I know there are very good reasons for it these days, but 30 years ago children did not travel to school by car. They walked to school. How many hours does your child sp

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

nd sitting in front of a TV set or a games console or a computer screen? How much sport do they participate in?

It is relatively easy for adults to determine whether or not they are overweight by working out the Body Mass Index, which is n

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

Professional from academic institutions, pharmaceutical industries, health care indust

t an appropriate measurement tool for children. Charts taking into account a child’s rate of growth, age, gender are used instead. Health professionals are able to measure what proportion of their weight is fat. As a rule, a child’s weight i

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

s generally classed as obese if the body weight is more that 25% fat in males and 32% fat in females.

Unfortunately far too many children have considerably more body fat then that, and we, as adults and their parents, are failing them. Th

.

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

y will not thank us in years to come for failing them in this way. Don’t blame the overweight child. Blame the parent, if there is any blame. Some is due to genetics or illness, but only a relatively very small amount.

P.S. As an adjunct

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

Companies that provide selfless information through particip

to this article you can find a Body Mass Indicator suitable for children and teens, and an extended version of this article, on our website here:

http://www.childhood-diseases-online.com/overweight-children.html

Copyright 2006 Peter Nisbe

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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