Advice Pool - Health and Fitness

Diabetes is a disease that no one wants, but many people have. It is simply a condition that results from the body’s ina

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

bility to produce or use insulin in the correct form. Insulin is key in this disease, because it is the hormone the body

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

Examples of combination products may in

produces to enable it to transform sugar, starch and other foods into energy. When insulin levels are too low, the gluc

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

ose, or sugar, levels in the blood are too high and damage to vital organs can be done.

While diabetes is a fairly trea

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

able condition, it is one that has no single known cause or cure. There is work being done to find a cure, but the road

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

Combination pro

ahead is still long. Considering this, those who suffer from this condition must generally resign themselves to a lifeti

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

me of regulating food intake and insulin levels. When a careful balancing act is performed, the chances of developing ne

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

ative side effects of the disease can be minimized greatly.

It is estimated some 20.8 million people of all ages in the

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

United States have this condition. Of those, more than 6 million likely don't even know they have the disease. When it

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

comes to diabetes, knowing is half the battle. Acting is the other half.

There are three major types of diabetes and th

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

treatments recommended might vary depending on which form presents. The forms are:

Type 1 diabetes: This is also known

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

Following aspects would a

as “juvenile diabetes.” In this condition, a person’s body does not produce the necessary insulin on its own. This form

dd to the challenges in developing combination products:

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

of the disease is fairly rare in the grand scheme of things, but it can be the most difficult to regulate.

Type 2 diab

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

etes: This form of diabetes tends to strike people as they get older. In this form, the person who suffers has an inabil

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

ty to use insulin properly. This is the most common form of diabetes.

Gestational diabetes: This is a temporary form of

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

diabetes that can strike a woman while she is pregnant. Uncontrolled gestational diabetes can present problems for the

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

Professional from academic institutions, pharmaceutical industries, health care indust

baby, including high birth weights.

The treatments for diabetes range from diet and exercise changes to the introductio

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

of insulin through shots. It will depend on the type of diabetes present and the severity of it before a treatment plan

.

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

can be made.

Diabetes is no laughing matter, but it can be a condition that’s controllable. Although there’s no guaran

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

Companies that provide selfless information through particip

tee strict control will prevent side effects, such as blindness and kidney failure, it can go a long way toward doing so

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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Advice Pool - The Diabetes Dilemma - Knowing What Diabetes Is Is Just Half The Battle

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