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Our country is becoming more and more concerned with Type II diabetes, particularly as the rate of obesity climbs. We need to be concerned with ways to prevent diabetes in both our adults and in children. We know that weight mainte

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

nance, diet and exercise are critical to preventing diabetes, but research is showing that there may be other things we can do to prevent diabetes, too.

Diabetes is a disease in which the body does not produce or properly use insu

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

Examples of combination products may in

in, the hormone that converts sugar and other food into energy. The most common type of diabetes seen today is Type II, where insulin is produced (though sometimes not in a high enough quantity), but is not used properly, resulting

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

in a high level of blood glucose in the body. Type I diabetes is diagnosed in childhood, and results from an inability to produce insulin.

Doctors are not entirely sure of the cause of diabetes, but we do know that people who are

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

bese and who do not get regular exercise are at a much greater risk of developing Type II diabetes than those who exercise and maintain a healthy weight.

Today, there are about 20.8 million people in the US with diabetes, and near

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

Combination pro

y one third of them don’t even know they have the disease. In addition, about 54 million people in the US are pre-diabetic, meaning their blood glucose levels are higher than normal, but not high enough to be diagnosed with diabete

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

. Complications from diabetes include blindness, cataracts, kidney problems, heart disease, stroke, nerve damage and foot and skin problems.

In addition to losing weight and getting regular exercise, it appears that drinking gree

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

tea may also help prevent diabetes and its complications. One study, conducted by the University of Scranton conducted studies on diabetic mice to determine the effects of tea on blood sugar levels. They fed them green and black t

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

a for a period of three months before beginning to evaluate them.

The rats were fed the equivalent of less than 5 cups per day to humans. The study found that both green and black tea decreased blood glucose levels over those of t

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

e mice who were not fed tea. These decreased glucose levels had the power to also reduce the complications of diabetes affecting the mice.

For example, the mice that were fed tea were far less likely to have begun to form cataract

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

, a common complication of diabetes, over the mice that were not fed tea.

This is promising news for those at risk of developing Type II diabetes. Of course, if you’re overweight or inactive, it’s still critical that you get movin

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

Following aspects would a

g and lose the excess pounds. Maintaining a normal weight and exercising regularly are the two most important steps you can take to preventing diabetes.

But, if drinking tea can help you win the fight, it’s certainly a simple step

dd to the challenges in developing combination products:

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

to take. And, this particular study did not show a difference between drinking green tea and black tea.

In recent years, most of the medical research done on tea has focused on green tea, and it has been widely assumed that green

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

ea provides more health benefits than black tea.

This assumption has been made because green tea retains more of its natural anti-oxidants than black tea. Black tea is fermented when it is processed; green tea is not. During this

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

rocessing, some of the anti-oxidants, namely EGCG are nearly destroyed.

Because EGCG is though to be one of the most important anti-oxidants in tea, it has been thought that green tea is far more beneficial than black tea. Howev

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

r, this does not appear to be the case when it comes to preventing Type II diabetes and its complications. It appears that either type of tea is able to regulate blood sugar naturally. This is certainly good news for those who pref

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

Professional from academic institutions, pharmaceutical industries, health care indust

r black tea over green.

If you’re concerned about your blood sugar levels, see your doctor. He’ll help you to begin a diet that will help your body be more able to regulate its insulin level. He’ll also help you to map out an exer

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

ise program that can help you lose weight – but also one that can help you burn carbohydrates more efficiently right away, helping to regulate your blood sugar immediately.

And, while you’re visiting with your doctor, be sure to t

.

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

lk to him about drinking tea. Tea has no known side effects, and is well tolerated by almost everyone. It even has lower caffeine content than coffee and soda. So, there should be no reason why you can’t use tea as part of your pla

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

Companies that provide selfless information through particip

to get your blood sugar level under control and prevent diabetes.

Your health is important – and diabetes can be a significant concern. So, take a look at the steps you need to take to prevent diabetes before it ruins your health

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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