Advice Pool - Health and Fitness

Millions of people in the developed world have diabetes, and it is a growing problem. The majority of sufferers have Type 2 diabetes which occurs when th

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

e body is not making enough insulin to regulate the level of glucose in the blood, or when the body is unable to process the insulin that is there. This

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

Examples of combination products may in

type of diabetes was traditionally found in adults, but an increasing number of children are now being diagnosed, and the disease is often linked to obesi

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

y.

What are the causes of Diabetes?

Diabetes is caused by a combination of genetic and environmental factors. It is now generally accepted that the foo

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

d we eat can be a trigger for diabetes. Scientists at various research laboratories have regularly reported that the high- sugar, high-fat Western diet ma

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

Combination pro

y increase our risk of Type 2 diabetes considerably. There is no doubt that obesity plays a huge part in the development of diabetes, and people with hig

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

blood pressure or circulation problems are also more likely to develop the disease.

Common Symptoms

Diabetes can develop very slowly, and symptoms are

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

sometimes so vague that people can dismiss them as just a case of being slightly unwell. This is why a large percentage of people remain undiagnosed. Very

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

often diabetes is discovered when a patient is being tested for something else entirely. Some of the more noticeable symptoms of diabetes are feeling th

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

rsty all the time, increased tiredness, and unexplained weight loss. Whatever the symptoms, early diagnosis is crucial to reduce the risk of serious lon

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

g-term complications such as kidney problems, nerve damage and sight loss. These can develop over time because high levels of glucose in the blood can per

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

Following aspects would a

manently damage blood vessels.

Managing Type 2 Diabetes

Many people with Type 2 diabetes are able to control the condition by regulating their diet and

dd to the challenges in developing combination products:

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

y exercising. This, of course, will have the added benefit of helping them to lose any excess weight. However, as well as diet and exercise, there are tho

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

se who will need to take medication or have insulin injections to lower blood glucose levels.

Living with Diabetes

So, if you have just been diagnosed w

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

ith diabetes, what changes do you have to make to your lifestyle? One of the first things people worry about is food and drink and what they have to avoid

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

A diabetic diet sheet should be available from your medical practitioner, but in general, if you avoid fizzy drinks, and processed foods, and eat as much

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

Professional from academic institutions, pharmaceutical industries, health care indust

fresh produce as possible, you will be surprised at how well you can actually eat! Because of it’s high sugar content, alcohol is best avoided, but some

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

people do find that the occasional glass of wine can be tolerated without adverse effects. The fact to bear in mind is that a healthy diet for people wit

.

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

diabetes is the same as that recommended for everyone, low in fat, salt, and sugar, and including starchy foods like bread and pasta.

There is no doubt

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

Companies that provide selfless information through particip

that diabetes is a serious condition for which there is no cure, but properly diagnosed and managed, it is possible to stay healthy and live a normal life

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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