E-Articles - Health and Fitness

Even if you have high cholesterol levels you will generally continue to feel quite well. You may be quite unaware that you are at risk from heart disease as gene

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

rally there are no warning signs of the lurking dangers.

What is cholesterol?

Cholesterol is a fatty substance in your blood produced natural

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

Examples of combination products may in

ly by your body and is essential to the adequate functioning of all the cells in your body. While most of the cholesterol in your blood is produced by your liver

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

, additional cholesterol also comes from some foods you eat, particularly those with high levels of saturated fats. The fats produced by your liver travel throug

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

h your blood as particles. These particles are known as low-density lipoprotein [LDL] and high-density lipoprotein [HDL.

Of these two types of blood-borne parti

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

Combination pro

cles, LDL is regarded as the bad cholesterol because it is likely to clog your blood vessels. HDL on the other hand, can help unclog arteries, minimizing your ch

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

ances of heart disease, and hence is regarded a good cholesterol.

What does a high cholesterol level do?

The major cause of heart disease is a

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

build up of fatty substances in the inner linings of the main arteries of your heart as a result of high levels of LDL cholesterol. This build up causes cloggin

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

g of the arteries, preventing an adequate blood supply to carry oxygen to organs and tissues throughout your body.

What can I do about my cholesterol l

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

evels?

It is important to seek medical advice in order to have your LDL and HDL levels accurately assessed. Then, depending on what other risk factors

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

you may have, you can make appropriate lifestyle changes to lower your cholesterol level.

The major factors in the development of high cholesterol levels are:

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

Following aspects would a

genetic factors you may have inherited;
a diet rich in saturated fats;
not getting enough daily exercise.

You can

dd to the challenges in developing combination products:

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

do little about the first of these yourself as you cannot change this! You can however, make significant changes in your lifestyle with beneficial effects on t

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

he other two of these major factors.

Reducing the amount of saturated fat in your diet will not only bring about lowering of your LDL levels but also help you m

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

aintain a healthy weight level appropriate for your body type and your age.

Ensuring you have an adequate level of daily physical activity will have a beneficia

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 effect not only on your cholesterol level by helping you maintain your healthy weight but will also assist you to keep your blood pressure at a normal level.

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

Professional from academic institutions, pharmaceutical industries, health care indust

If your doctor is believes that, despite your lifestyle changes, you have some adverse genetic factors, he can prescribe medication which, together with suitable

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

diet and adequate exercise, can make significant changes to your cholesterol levels.

Summary: Keeping your cholesterol in control:

.

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

i> eat a healthy diet;

try to keep your weight at an appropriate level;

take part in some physical activity most days;

keep

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

Companies that provide selfless information through particip

your blood pressure at a normal level:

take medication if prescribed by your doctor;

in addition, if you are a smoker STOP NOW.

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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