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This article is intended strictly for those who have type 2 Diabetes and have it under control and those who could have it under control but lack the will to do so. First what is Diabetes and how does it affect the body. Type 2 Diabet

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

es usually occurs in early or late adult hood. It could be inherited or caused by over eating. not eating the right foods, lack of exercise, obesity, or a combination of all.

The medical term for Diabetes or Sugar Diabetes as it is ca

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

Examples of combination products may in

led in lay terms is Diabetes Mellitus. It is the body's inability to break down sugars which are called glucose which supplies the body energy to function. The body either does not have or does not make enough insulin which is used to

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

control this glucose. The symptoms of Diabetes Mellitus are hunger, excessive thirst which is called polydipsia, and excessive urination which is called polyuria. Also high blood pressure is caused by Diabetes. Lack of sugar control

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

lso can cause blindness, loss of limbs, teeth, slow healing of wounds which could lead to gangrene and eventual premature death. So as you can see under no uncertain terms can you take it lightly. It is one of the leading killers in t

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

Combination pro

he United States and is reaching epidemic proportions. One of the most difficult things about Diabetes is that you have to control your natural apatite which you need to help to keep you alive. You naturally want to eat and you are now

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

being asked to curb this to save your life.

If you are a Diabetic you already know that controlling the amount of carbohydrates that you take in helps control your sugar levels. Eating proper foods in the right amounts with moderate

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

exercise, meal planning and taking your medication if prescribed as you should, can help control your sugar levels. Also checking your sugar levels as much as 4 times a day depending on what your doctor and health professionals tell y

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

u, can help you make the necessary adjustments to keep your sugar levels healthy. White bread, corn, potatoes, waxed beans, and white rice to name a few are foods that contain carbohydrates. However I am not going to get in to that i

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

n this article.

There are several key issues that need to be discussed. These are neglect, lack of responsibility. peer pressure, temptation and will power. Just as in any other situation Diabetes must be taken seriously. You have a

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

obligation to yourself, your family, and your friends not to let them down. This is also a two way street. Your family and friends, if they care anything about you have an obligation to you. Often Diabetics are made to feel guilty b

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

Following aspects would a

such words as go ahead it's not going to hurt you just this once, don't let Diabetes control you, I'm glad I don't have to eat like that. How would they feel if you were lying in the hospital in a comma, with serious wounds and sores

dd to the challenges in developing combination products:

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

that wouldn't heal and missing a limb because you listened to them and now you became a burden to them. On the other hand how would you feel if you neglected your obligation to your family because you neglected yourself. Imagine how

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

t would feel to your family if they had to plan your funeral, you missed your child's graduation, or could not go on a family vacation because you neglected yourself by giving in to temptations and not taking the time to manage and car

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

e for your Diabetes. As I said earlier it is not different from any other responsibility. Neglecting yourself is no different than misusing drugs or alcohol. In some cases Diabetes is so severe such as in the case of type 1 Diabetes

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

t requires constant attention and care. Even in some cases of type 2 Diabetes the body simply just stops making insulin and that is no fault of anyone's. However in any instance working with your doctor to stay as well as you possibly

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

Professional from academic institutions, pharmaceutical industries, health care indust

can lies with you.

Get serious. Talk to your health professional and your doctor about planning meals, balancing diet and exercise, form a support group. Learn what you can eat to act as a filler when you are hungry. There are vegetab

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

es, for example that do not add to your sugar levels. You can drink low sodium vegetable drinks, eat nuts in the right amounts, eat snacks made especially for diabetics. These could be in the form of candy bars and drinks.

Keeping you

.

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

r sugar under control can help you lead a near normal life and could help you avoid prolonged illness, suffering, being an unnecessary, burden to your friends and family, loosing work and income, and avoid premature death. There is no

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

Companies that provide selfless information through particip

ure as of yet for Diabetes but it can be controlled and slowed down. Letting managing your Diabetes become an integral part of your life can make a differennce in the quality and longevity of your life, happiness and overall well being

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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