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What cause high blood cholesterol? There are many factors causes high blood cholesterol levels, some of these factors are w

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

ithin your control, some are not and people lifestyle affect cholesterol levels too.

What causes high blood cholesterol? T

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

Examples of combination products may in

e following factors are the most important cause’s high blood cholesterol.

• Heredity plays a role in high cholesterol. Y

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

our genes can influence your LDL by affecting how fast it is made and removed from your blood. There is one particular for

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

of inherited high cholesterol that will often lead to early heart disease. It is called familial “hypercholesterolemia” w

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

Combination pro

ich means that very high cholesterol levels run in the family and can play a role in 1 of 500 people.

• Weight is a factor

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

in determining your LDL. If you are overweight and have a high LDL level, try to losing those pounds may help you to lowe

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

it. And also losing weight helps to lower triglycerides and raise your HDL.

• What you eat. Eating too much saturated fa

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

t and cholesterol is the main reason for high levels of cholesterol because your body makes more cholesterol, and raising y

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

ur blood cholesterol levels. You can reduce your cholesterol level by cutting down on the amount of saturated fat (animal

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

at and dairy products) and cholesterol you eat.

• Age and sex should be considered as well. Women, before menopause, usual

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

Following aspects would a

ly have total cholesterol levels that are lower than men, because they get a natural boost in their HDL cholesterol from th

dd to the challenges in developing combination products:

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

ir hormones. But after Menopause can cause an increase in LDL and a decrease in HDL. After the age of 50 women often have

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

higher total cholesterol levels than men of the same age.

• Stress may contribute to raise blood cholesterol level. When p

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

ople are under stress, they may do something that can affect their behavior such as smoking, alcohol, or eat fatty foods to

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

console themselves.

• Exercise regularly can increase HDL ‘good’ cholesterol and decrease LDL ‘bad’ cholesterol.

There ar

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

Professional from academic institutions, pharmaceutical industries, health care indust

e some factors that can cause high blood cholesterol levels. Now you understand how high cholesterol can be serious problem

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

to your health that can lead to heart attack and stroke, so Lower your cholesterol is important for key to prevent this pro

.

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

blem. Read more : Lowering Cholesterol

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

Companies that provide selfless information through particip

Naturally

(c) 2007 - Lower Cholesterol Center

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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