Advice Pool - Health and Fitness

With Hepatitis C affecting millions of people in the United States, many people find themselves wondering ju

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

st how the virus is able to get past the body’s immune system and develop into a chronic illness. The immune

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

Examples of combination products may in

system is supposed to be the body’s line of defense against disease, fighting until the virus or bacteria is

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

diminished. So how does the immune system succumb to the Hepatitis C virus so easily? Scientific research ha

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

uncovered the virus’ ability to change its form when confronted by immune cells, thus being able to sneak p

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

Combination pro

st and establish itself in the body. At this point, chronic liver disease is imminent.

The Hepatitis C viru

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

is smart and knows exactly how to maneuver its way past the immune system. Think of it in terms of a battle

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

: the immune system is working hard to defend its territory (the body), which the HCV is trying to invade. P

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

rt of the virus is keeping the immune system occupied, while another part gets through, settling in the body

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

The immune systems of some people may be strong and healthy enough to keep the virus at bay. For others, th

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

ir immune systems simply are no match for HCV, offering minimal protection against the disease.

This may so

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

Following aspects would a

nd like a no-win situation, but the more we learn about the evolution of the virus, the closer we are to fin

dd to the challenges in developing combination products:

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

ing a vaccine or a cure for it. As research continues, there are some simple behaviors you can adopt to help

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

strengthen your immune system. Getting enough sleep, eating nutritious foods, and avoiding alcohol and any o

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

ther toxic substances that pose a threat to the health of your liver, are all ways to help prevent liver dis

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

ase from progressing into a chronic illness.

Now that researchers have been able to pinpoint exactly how th

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

Professional from academic institutions, pharmaceutical industries, health care indust

Hepatitis C virus escapes the immune system, there is increased hope for its defeat.

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

ef="http://www.hepatitis-central.com/mt/archives/2007/03/post_2.html" target="_blank">Click here to

.

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

ead this article in its entirety and learn more about how HCV is able to distract the immune system long eno

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

Companies that provide selfless information through particip

gh for it to turn into a chronic disease, and what preventive steps you can take to stop this from happening

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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