E-Articles - Health and Fitness

Cholesterol. Boy, there sure is a lot of noise being made about keeping your cholesterol low. You can see ads for all kinds of drugs all over the TV to hel

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

p lower your cholesterol. Go to a doctor’s office and the first thing you see hanging on the wall is a cholesterol chart.

So what exactly IS cholesterol an

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

Examples of combination products may in

d what's the big deal about it? In this article we'll try to answer some of those common questions.

For starters, all cholesterol is not bad. In fact, it'

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 produced naturally in your liver and it helps with important body functions. It's the bad cholesterol, called LDL (low density lipoprotein) that can reall

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

y do you in. Get too much of this in your system and it can lead to heart disease. Unfortunately this can be something you inherit from your ancestors, mea

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

Combination pro

ning there isn't much you can do about getting it, not that it can't still be controlled. We'll get to that later. The more common cause of high LDL is poo

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

r diet, usually one that's high in saturated fats. Add to that lack of exercise and you've got a real problem on your hands.

In 2003 it was estimated that

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

bout 50 million men had high cholesterol greater than 200. Oh yes, the numbers. How they come up with these figures isn't important. What is important is

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

that it has been determined that a cholesterol level above 240 is considered high and risky. A person with a level above 240 has twice the risk of heart dis

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

ease compared with someone who's cholesterol is below 200. The magic number seems to be below 200. That's when you are no longer considered to have high ch

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

olesterol. According to the National Cholesterol Education Program (NCEP) you should have your cholesterol checked at least once every five years. All that

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

Following aspects would a

is needed to do this is a simple blood test.

So what happens when you get high cholesterol? How can you treat it?

Without having to take drugs, which is

dd to the challenges in developing combination products:

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

the last resort, the best way to lower your cholesterol is to change your diet. Eat fewer foods that are high in saturated fats and exercise regularly. The

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

most common foods to avoid are fatty meats, deli, bacon, peanut butter, unless it specifically says it is low in cholesterol and anything coming out of a fa

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

t food chain such as fried food and onion rings. Also eating lots of fruits and vegetables will help in lowering cholesterol levels. If you smoke, by quitt

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

ing, you will lower your cholesterol level. Also drinking alcohol in moderation will help to lower cholesterol levels,

If diet and exercise aren't enough,

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

Professional from academic institutions, pharmaceutical industries, health care indust

there are drugs that can help to lower your cholesterol. The most popular of these drugs is Lipitor. What Lipitor does is lower the level of LDL produced b

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

y your liver, usually by 39 to 60%.

While cholesterol can be extremely dangerous it is actually one of the easiest things in your body to control between di

.

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

et and exercise and if need be, with prescription drugs. There is no need for anyone to suffer from heart disease because of high cholesterol. It is an eas

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

Companies that provide selfless information through particip

ily treated disease. So see your doctor and get a blood test. If you have high cholesterol speak to him about how you can lower it. You'll be glad you did

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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