Advice Pool - Health and Fitness

Hypercholesterolemia is one the biggest risk factors for developing coronary heart disease. Cholesterol tends to accumulate in the walls of your arteries, formin

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

g plaques. These plaques cause the arterial walls to narrow and harden, making it difficult for your heart to pump blood. This condition is known as atherosclero

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

Examples of combination products may in

is, and is often a precursor to serious cardiac conditions such as angina, heart disease and cardiac arrest.

Cholesterol is important to the normal physiology o

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

your body. Your liver manufactures some cholesterol and the rest is obtained from your diet. Obviously, you can control what you eat, but not what your liver pr

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

duces, so dietary restriction is a crucial to maintaining good cholesterol levels. So what is a healthy cholesterol level?

To complicate matters, not all choles

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

Combination pro

erol is bad for you. Low density lipoproteins (LDL) are a sub-type of cholesterol that contribute to atherosclerosis and the associated cardiac complaints. By co

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

ntrast, high density lipoproteins (HDL) are a form of cholesterol that work as scavengers. HDL cholesterol prompts the extraction of LDL cholesterol from the art

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

ries and delivers it back to the liver, where it is excreted.

When you have your cholesterol tested, your doctor will look at several things. First, your overal

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

cholesterol level will be examined. Total cholesterol is measured as a concentration and ideally, it should be less than 200mg/dL. If your levels are between 20

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

and 239mg/dL, your cardiac risk is classified as borderline high. Above 240mg/dL, your blood cholesterol is high and your risk of heart disease is substantially

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

elevated.

Your doctor will also check your HDL or “good” cholesterol level – these should ideally be more than 60mg/dL. Having a HDL concentration of between 40

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

Following aspects would a

to 59mg/dL means your cardiac risk is fair, whilst HDL levels below 39mg/dL confer high cardiac risk. With LDL concentration, the lower the number the better –

dd to the challenges in developing combination products:

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

ess than 100mg/dL is satisfactory, whereas anything above this level is undesirable. LDL levels between 101 and 159mg/dL are considered to be borderline high, wh

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

lst from 160mg/dL to 189mg/dL your levels are high. Above 190mg/dL is an excessively high LDL cholesterol level.

Finally, your doctor will examine your triglyce

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

ide level. Triglycerides are the most common type of fat in your body and are used as an energy source. As you age and weight increase, so too do your triglyceri

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

e levels. Ideally, your triglycerides should be less than 150mg/dL. Once they rise above 151mg/dL, your levels are considered borderline high. At 200-499mg/dL, y

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

Professional from academic institutions, pharmaceutical industries, health care indust

our levels are high and your risk of ill health is substantially elevated. Beyond 500mg/dL your triglycerides are very high and your health may be in jeopardy.

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

f your cholesterol levels are high, or borderline high, it will be your doctor’s first goal to lower your total cholesterol. You’ll need to restrict the amount o

.

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

high-cholesterol foods you eat, start exercising regularly and attempt to lose any excess weight. If these methods fail to work, you may need to look at alterna

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

Companies that provide selfless information through particip

e ways to lower cholesterol such as taking cholesterol-lowering medication in order to reduce your risk of coronary heart disease and other associated conditions

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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