Advice Pool - Health and Fitness

Having been diagnosed with diabetes, in order to slow down the inevitable complications that are going to arise, you need to start making some changes in your lifestyle. In some cases, those changes could be quite drastic but 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

ey will soon be brought into context when compared to the seriousness of acute or chronic consequences that the complications of diabetes can cause.

OK. Let's be blunt. Diabetes can kill! The acute complications associated with

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

Examples of combination products may in

diabetes, if not treated immediately and correctly can be severe, resulting in coma or even death. That's how serious this disease can become and that's why it's important that you come to understand the complications involved.

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

The major acute complications of diabetes:

* Diabetic Ketoacidosis (DKA) - Predominantly affects sufferers of type 1 diabetes. Ketoacidosis means the presence of dangerously high levels of ketones, acids that build up in your

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

lood. When your body isn't producing an adequate amount of insulin, these ketones will appear in the urine. The important thing to note here is that ketones are poisonous to the body, and their presence is an indication your dia

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

Combination pro

betes control has failed or that you are getting sick.

* Hyperglycemic Hyperosmolar Non-Ketotic Syndrome (HHNS) - Can affect sufferers of both type 1 and type 2 diabetes, but normally seen in type 2 diabetes. In HHNS, your body

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

produces above normal amounts of urine in order to get rid of excess blood sugar, resulting in your having to go to the bathroom more often. As this progresses, less urine is produced as your body starts to dehydrate. If this co

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

ntinues, the severe dehydration will lead to seizures, coma and eventually death. It must be noted that HHNS may take days or even weeks to develop.

* Hypoglycemia - This is basically very low blood sugar, and can be brought on

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

due to errors with medication or maybe not being able to eat properly due to ill health or sickness.

The major chronic complications of diabetes:

* Kidney failure - This is one of the biggest problems faced by diabetes suffere

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

rs.

* Diabetic Neuropathy - If you are unfortunate enough to contract this complication of diabetes, then you will start to experience a loss of feeling or constant pain due to a loss of nerve function in the body.

* Erectile

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

ysfunction - Another chronic complication associated with diabetes and is normally caused by a combination of neurological and vascular damage.

Other chronic diabetes complications can include coronary heart disease, diabetic r

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

Following aspects would a

tinopathy, normally resulting in blindness and cerebrovascular disease.

Now can you understand the importance for the changes in lifestyle? But what changes do you need to make? Well first and foremost is a change to your diet,

dd to the challenges in developing combination products:

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

and this doesn't mean that you are now going to have to endure a boring diabetes diet full of tasteless foods and other foodstuffs that you don't like. Just watch what you eat. Cut back on the amounts you eat and avoid foods th

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

t are high in sugars. Pay a visit to your doctor, diabetes advisor or dietician and with their help, learn to read the food labels so you can pick the foods that aren't bad for you.

Whilst we're on the subject of food, another

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

change you are going to have to make is to monitor your blood sugar levels. You need to learn how food and exercise affects your body. Your doctor will probably have you check your blood sugar levels before AND after meals so yo

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

can see the differences in levels. This will enable to you to make comparisons between how much food you eat and to what levels your blood sugar rises. Check your bloods before and after any exercise as well. This will help to

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

Professional from academic institutions, pharmaceutical industries, health care indust

make sure you avoid one of the acute complications of diabetes, hypoglycemia.

Another important thing you should do is to make people around or involved with you aware that you are diabetic. Co-workers, friends, family. They sh

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

uld all be made aware of the signs and symptoms of diabetes and more importantly the signs and treatments of a hypo or hypoglycemia so they can get any immediate treatment required.

This information has been provided as a guide

.

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

to the problems that are associated with diabetes. It is of the utmost importance that if you suspect that you could be experiencing any of the complications mentioned above, or you experience any changes in your medical condit

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

Companies that provide selfless information through particip

on, that you seek expert medical advice from your doctor. With a good care regime, changes to your lifestyle and careful monitoring of your diabetes, there is absolutely no reason why you can't continue to enjoy life to the full

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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