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Children, like adults, are often diagnosed with diabetes. Most children have type 1 or juvenile diabetes that will require insulin on a regular basis to susta

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

in proper body functions. There are growing numbers of children that are now being diagnoses with type 2 diabetes that has historically only been found in adu

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

Examples of combination products may in

t populations.

Some facts about children and diabetes highlight the importance of understanding this disease and finding ways to manage and control it effect

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

vely:

* One in every 400-500 children in the world has diabetes.
* Approximately 150,000 children in the United States under the age of 18 have diabete

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

.
* Type 1 or juvenile diabetes occurs when the immune system begins to generate cells that destroy the pancreatic cells responsible for producing insuli

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

Combination pro

n in the body. If the child does not receive insulin every day the child will die.
* 13,000 children are diagnosed with type 1 diabetes every year. These

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

children are at a greater risk for heart attack, stroke, kidney disease and immune complications throughout their lives.
* Type 2 or adult onset diagnosi

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

is becoming more prevalent in children. This is a condition where the body is unable to utilize the insulin produced because it has built up a resistance to

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

he insulin. Over time the pancreas is unable to produce sufficient quantities of insulin, and complications arise.
* Type 2 diabetes is more closely link

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

ed to obesity, especially if there is a history of diabetes in the family. It is also more prevalent in African American, Latino, Asian, and American Indian c

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

ildren.

Controlling diabetes in children

Just like adults, children diagnosed with type 2 diabetes will need to closely monitor both their food intake and t

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

Following aspects would a

e amount of exercise that they complete each day. While not required to eliminate all their favorite foods, it is important to teach children concepts of port

dd to the challenges in developing combination products:

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

on control and healthy eating. Often in todays culture there is so much to get done in a day that meals are often skipped or eaten on the run or in the car. F

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

ast foods are not a good substitute for fresh fruits and vegetables, lean meats and whole grains.

Try to schedule so that your child has time to sit down to

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

balanced meal as often as possible, ideally three times per day. Try to include whole grains, fiber, lean meats, fish, dairy products and fresh fruits and ve

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

etables. To get children to eat healthy try the following:

* Trail mix including a variety of nuts, dried soy nuts, dried fruits instead of potato chips.

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

Professional from academic institutions, pharmaceutical industries, health care indust

* Granola bars instead of cookies or donuts.
* Whole grain bread instead of white bread.
* Carrot and celery sticks instead of French fries
*

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

Bake foods instead of deep frying
* Salads with meals or as an appetizer before meals
* Raw vegetables or fruits dipped in yogurt

Remember that mo

.

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

eling healthy lifestyles will help your children learn. Exercise together as a family. Go for a bike ride, walk, or go to the park and have fun together. Smal

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

Companies that provide selfless information through particip

changes in lifestyles can lead to big changes in health conditions over time. Start small and work together as a family to reach your diet and exercise goals

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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For an industry whose very name indicates that it involves marketing, this is often the most overlooked and least understood aspect for the majority of distributors. For with out marketing, you do not have a business and will make no money.

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