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Cholesterol is both friend and foe. While we cannot live with out it, in extreme amounts it can kill us. The blood cholesterol level is t

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

he single most important factor in shaping a person's risk for heart disease. It does it by plugging up vital heart-nourishing arteries 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

rough the process called atherosclerosis.

Most heart attacks are linked to plaques, which are made up mostly of cholesterol and fat. Pla

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

ues are like patches. They are the body's response to damaged areas in arterial walls which are caused by free radicals, especially those

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

found in oxidized cholesterol. The body responds to the nuisance by adding more and more "patches" to protect the area, causing the plaqu

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

Combination pro

to slowly expand. But in doing so it also slows the blood flow and may ultimately block the artery entirely.

When blood cholesterol lev

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

els are under 150 mg, early arterial damage usually heals quickly and the scars get smaller. But when cholesterol levels edge past 180, L

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

L-cholesterol begins to fasten itself to the vessel walls, causing atherosclerosis (narrowing of the arteries, and plaque formation).

Al

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

hough cholesterol can be a problem it is also an essential for us to survive, but we do not have to eat it. The liver manufactures all th

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

cholesterol the body needs. But most of us eat an additional 300 milligrams of cholesterol a day. It's this extra dietary cholesterol th

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

t causes a sizeable part of the problem.

Cholesterol never travels alone -- in the blood it has different carriers. The heaviest carrier

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

Following aspects would a

is HDL (high-density lipoprotein), known as the "good" cholesterol. HDL is protective because it removes cholesterol from arteries and t

dd to the challenges in developing combination products:

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

kes it to the liver, where it is made into bile. The higher the HDL in the blood, the better the protection. Men with HDL over 75 mg are

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

rotected from heart attacks.

A simple way to calculate heart attack risk is to divide the total cholesterol by the HDL. Preferably it sh

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

uld be under 4.0. A lighter carrier, the LDL (low-density lipoprotein), is the "bad" one. LDL basically determines the rate at which chol

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

sterol is deposited on artery walls. To be safe, LDL should be under 90 mg.

While there are other carriers, LDL and HDL are the two most

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

Professional from academic institutions, pharmaceutical industries, health care indust

important ones.

Even though the foe can kill us in excess, the friend is very important in the manufacturing and preservation of cell m

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

mbranes. It regulates membrane flexibility over a wider variety of temperatures. Cholesterol also aids in the manufacture of bile (which

.

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

stored in the gallbladder to help with the digestion of fats), and is also important for the metabolism of vitamins, including vitamins A

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

Companies that provide selfless information through particip

D, E and K. It is a major forerunner for the fusion of vitamin D and of the various hormones (which include estrogens, and testosterone)

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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This is part nine in my series on goals. These can be used in anything from affiliate marketing to real life romance. Please tell others about this series as I think there are things that can benefit everyone in some way.

Christopher Dunn has other insights which I report upon elsewhere but this is one of the technologies the ancients used.

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