Advice Pool - Health and Fitness

You will frequently hear statement like “eating too much sugar causes diabetes. Diabetes will be cure if we avoid sweet food.” This is

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

certainly untrue because diabetes is not just a sugar problem, it is an incurable condition! Nevertheless, eating too much sugar will

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

Examples of combination products may in

definitely not cause diabetes. Instead, factors such as genetics, ageing, obesity, unhealthy diet, and sedentary lifestyle may be the

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

possible contributory causes. Diabetics can still stay healthy if their blood sugar levels are well controlled with proper diet, healt

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

hy lifestyle and effective medications. Uncontrolled or poorly managed diabetes may, however, lead to dangerous complications.

What i

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

Combination pro

s diabetes? Diabetes is a very common medical condition. At least 171 million people worldwide have diabetes, according to the statist

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

cs recorded by World Health Organization (WHO). Diabetes is a disease characterized by excessively high blood sugar level. Food consum

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

ed is digested and released into blood as glucose (a form of sugar), to provide energy. When there is excess glucose, a hormone called

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

insulin will convert and store glucose in the body for future usage. Diabetes is due to defects in insulin production (Type 1 diabete

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

), insulin action (Type 2 diabetes), or both, causing a build up of blood glucose.

Diabetes is very serious. Unfortunately, many peop

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

le are unaware of this. Diabetes is not just a harmless, high blood sugar problem. Uncontrolled diabetes is debilitating with many sev

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

Following aspects would a

ere, life-threatening complications.

Firstly, uncontrolled blood glucose may lead to disturbing symptoms such as frequent urination,

dd to the challenges in developing combination products:

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

hirst, unexpected weight loss, extreme hunger, and frequent fatigue, etc.

Secondly, diabetes may also become comatose due to very hig

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

h blood glucose in untreated diabetes or during infections.

Thirdly, long standing uncontrolled diabetes may cause complications such

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

as kidney failure, heart disease, blindness, neuropathy (damage to nerves), lower-limb amputations, etc.

Last but not least, a medic

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

l crisis may also occur in abnormally low blood glucose due to taking excess insulin, a lack of food or too much exercise. During the

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

Professional from academic institutions, pharmaceutical industries, health care indust

crisis, the person turns pale, breathes rapidly and is disoriented, cold and trembling. A diabetic crisis is fatal if not treated in t

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

ime.

Diabetes is several times more prone to develop coronary heart disease and stroke! Cholesterol problems and blood vessel thicken

.

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

ng (atherosclerosis) are common ailments. Diabetics may also suffer from high blood pressure as a result of atherosclerosis. The risk

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

Companies that provide selfless information through particip

of dying from heart attacks is also higher. Sometimes, heart attack is painless and unrecognized in many diabetics who have neuropathy

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 - Diabetes Is Not Just A Matter Of Sugar

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