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Atherosclerosis, which is the development of lesions in arteries, is the underlying pathologic process that is responsible for coronary artery disease.

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

During childhood atherosclerosis may slowly cause a thickening, loss of elasticity, and calcification of the arterial walls, a condition known as arte

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

Examples of combination products may in

iosclerosis.

The most common and serious result of atherosclerosis is the development of lesions in coronary arteries that can cause chest pain known

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

s angina pectoris. Angina is caused when blood flow is partially blocked by a blood clot. If the blood flow to the heart is completely blocked a heart

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

ttack occurs.

If a blood clot occurs in a cerebral artery then a cerebrovascular accident or stroke can happen. Peripheral vascular disease occurs whe

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

Combination pro

atherosclerosis in the abdominal aorta, iliac arteries, and femoral arteries produces temporary insufficient blood flow in the arteries upon exertion.

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

This can lead to tissue death and gangrene of the extremities.

Diagnosing the risk of coronary artery disease is done by measuring cholesterol and pro

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

ortions of the different types of plasma lipoproteins that carry cholesterol in the blood. Cholesterol is not actually a lipid, but it travels in the b

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

oodstream in spherical particles called lipoproteins, which contain lipids and proteins. A precursor of bile acids and steroid hormones, cholesterol is

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

an essential component of cell membranes.

There are three classes of lipoproteins that are measured when analyzing cholesterol levels in a fasting ind

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

vidual:

• VLDL – Very low-density lipoproteins.

• LDL – Low-density lipoproteins.

• HDL – High-density lipoproteins.

60 to 70 percent of the total

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

Following aspects would a

erum cholesterol is made up of LDL-cholesterol and high serum levels are known to increase the risk of coronary artery disease. HDL cholesterol usually

dd to the challenges in developing combination products:

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

makes up 20 to 30 percent of the total cholesterol and higher levels reduce the risk for coronary artery disease. Triglycerides make up the majority of

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

the VLDL's and make up 10 to 15 percent of total serum cholesterol.

Of the three types of cholesterol two, LDL and VLDL, are considered to increase th

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

risk for this disease. There are any number of medical studies and clinical trials that prove that lowering LDL-cholesterol levels reduces the risk of

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

suffering from coronary artery disease.

The most common type of fat found in the body is triglycerides. The body gets triglyceride directly from foods

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

Professional from academic institutions, pharmaceutical industries, health care indust

and makes it in the liver from carbohydrates, alcohol, and some cholesterol. Factors that can raise triglyceride levels include:

• Obesity

• Sedentar

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

lifestyle

• Smoking

• Alcohol

• Eating high amounts of carbohydrates

• Other disease such as type 2 diabetes, chronic renal failure, and nephritic

.

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

syndrome

• Certain drugs

• Hereditary or genetic factors

For anyone who has coronary artery disease the treatment of choice is lifestyle change that

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

Companies that provide selfless information through particip

limits or eliminates the above risk factors. For those looking to prevent this disease living a healthy lifestyle is the key to a long and healthy life

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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MEDICINE'S use and ABUSE -- Friends, The study below done a few years ago should scare the socks off us all. We can do much better in this country

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