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As for keeping a heart healthy, consider this. The odds for a healthy heart are not cardiovascular friendly. In fact, the statistics speak for them

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

selves.

Over 1,000,000 die each year due to heart disease.
500,000 women every year die from heart disease, making it a concern for both men

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

Examples of combination products may in

nd women.
Every 60 seconds someone dies of a heart attack.
Sudden Cardiac death (SCD) accounts for 300,000 deaths each year - 1 every 60

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

seconds.
Get this, 95% die before reaching the hospital.
100,000 athletes die each year from SCD. Sixty percent of our youth are at risk

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

or heart disease.
Heart attacks kill more people than the next nine causes of death, combined.
Putting it into perspective, heart disease

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

Combination pro

is like Seven (7) Boeing 747 planes crashing with no survivors, everyday. WOW!

The human heart pumps five quarts of blood every minute, and it be

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

ts 10,000 times each day for 50, 75, 100 years or more. That is right. The human body contains about five quarts of blood. Day after day, year afte

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

r year, this organ, about the size of a man's fist, pumps approximately 45 million gallons of blood through the body over a 50-year period. In shor

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

, blood is the life of our bodies while the heart is the power that keeps it circulating. It is a fact that the number one cause of death in Americ

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

a is heart disease.

If the heart goes, it is all over! This makes protecting the heart a number one priority for every living being. Newspapers te

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

l the same story in the obituary columns across this nation. A young man or woman in the mid-years of life die of heart attacks daily. The untold p

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

Following aspects would a

rt of most of the obituaries is that the heart attack victim was a picture of health. So what happened? Is this a familiar picture? This is sad and

dd to the challenges in developing combination products:

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

frustrating for the loved ones of heart attack victims who are left behind. And the big question always is, “What could have been done?'' The old

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

dage says, "An ounce of prevention is worth a pound of cure.'' What is prevention and how can it be attained?As a rule, having nature and common se

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

nse as a foundation, is definitely a plus. One preventative step is to realize that all life on earth has been and is currently dependent on the ve

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

etable or herb kingdom. This is true for not only sustaining life but for maintaining health. Of course, there are no guarantees for results, but n

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

Professional from academic institutions, pharmaceutical industries, health care indust

othing usually is guaranteed. A popular heart enhancer is herbs, which are swiftly gaining much recognition and usage although they have been used

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

or thousands of years. These herbs, even before Hippocrates time, were covered in the Old and New Covenants of the Bible, King James Version, Ezeki

.

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

el 47:12 and Romans, 14:2, where it states, “...if you are weak, eat herbs (vegetables)”. Revelation 22:2 “...and the leaves are for the healing of

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

Companies that provide selfless information through particip

nations." Again in Psalms advice about consumption of herbs is given, 104:14, “...and the herb for the service of man."

http://www.robertbarner.co

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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