Advice Pool - Health and Fitness

Most people have heard the statistics for their own country. Cardiovascular disease is the number one leading cause of death – or number two or three. But what about other nation

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

s? Are their statistics similar to those of your nation? Is cardiovascular disease as prevalent in New Zealand as it is in Latin America? Is it as much a leading cause of death i

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

Examples of combination products may in

n Japan as it is in the Middle East Crescent?

What is the global prevalence of cardiovascular disease?

Global Prevalence of Cardiovascular Disease

The global prevalence

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

of cardiovascular disease is a big topic, given the fact that a number of different diseases fall into this large umbrella category.

The World Health Organization (WHO), however

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

, provides certain global health statistics from 1990 (Murray CJL & Lopez AD, 1996). Statistics are provided for Established Market Economies, which are Australia, Canada, Europe

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

Combination pro

Japan, New Zealand, and the USA. In addition, WHO provides statistics for formerly Socialist regions of the world as a group, India, China, other Asian and island regions, the g

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

roup of African regions south of the Sahara, Latin American and Caribbean countries, and countries in the Middle East crescent area.

From those statistics, we can see the global

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

prevalence of cardiovascular disease in three categories: coronary heart disease, stroke, and diabetes.

Coronary Heart Disease

Coronary heart disease, involving angina,

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

typically manifests itself as chest pain. The pain is caused by arterial blockage, which deprives the heart of vital oxygen.

The global prevalence of cardiovascular disease that

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

is coronary in nature appears to follow a fast-moving, stressful lifestyle. Coronary heart disease (CHD) is most prevalent in the Established Market Economies. In those combined

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

countries, 8.2 million people had the disease at the time of the study. India had 6.6 million cases. In former Socialist countries, the number was 5.8 million. The region with th

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

Following aspects would a

e lowest prevalence of coronary heart disease was sub-Saharan Africa. This may be due, at least in part, to the slow pace of life in that region.

Stroke

The global preva

dd to the challenges in developing combination products:

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

ence of cardiovascular disease that manifests as stroke also appears to follow a fast-moving, stressful lifestyle.

This study found 9.5 million cases of stroke in the Establishe

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

d Market Economies and only 1.3 million in sub-Saharan Africa. Interestingly, China was second in this category, 7.4 million people with stroke. Yet China ranked fourth in CHD, w

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

th 4.5 million people.

Diabetes

The Established Market Economies led the way again in global prevalence of cardiovascular disease manifested through diabetes. At the tim

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 of the study, 37.9 million people in these nations had diabetes. The runner-up was India, with less than half as many cases: 18.1 million. Sub-Saharan Africa had only 3.9 milli

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

Professional from academic institutions, pharmaceutical industries, health care indust

n cases.

In Summary

Having viewed the global prevalence of cardiovascular disease, one is forced to ask why. Why is it that regions with wealth, regions that hold some o

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

f the greatest medical expertise in the world, have a greater prevalence of cardiovascular disease? Why is it that strokes and diabetes strike more people in the metropolises of

.

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

he Established Market Economies than in the villages of Africa?

The layman can only conclude that, for all of our knowledge regarding cardiovascular disease, we are woefully lac

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

Companies that provide selfless information through particip

king in applying that knowledge to prevention.

CAUTION: The author is not a medical professional, and offers the information in this article for educational purposes only

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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