Advice Pool - Health and Fitness

Coffee is a beverage that is loved and consumed by millions of people yet its role in health is somehow controversial.

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

Over the years, numerous studies were conducted on its effect, either good or bad, on heart disease, diabetes and other

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

Examples of combination products may in

disease but no definite conclusion has been arrived so far.

A study done on more than 14,600 people in Finland, the he

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

viest coffee-drinking country, provided more evidence in March 2004 that the world’s most widely consumed beverage may

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

educe diabetes risk.

Women in Finland who drank 3 to 4 cups of coffee daily had a 29 percent reduced risk of diabetes.

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

Combination pro

Among men, the same amount of coffee consumed lowered the risk by 27 percent. The apparent protective effect, the mecha

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

ism of which remains a mystery, increased with consumption. Women who had intake of 10 or more cups a day had nearly 80

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

percent lowered risk, while men who had the same intake cut their risk by 55 percent. The average coffee consumption of

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

Finns is 9 cups per day and the country tops world per capita consumption at more than 10.8 kg a person annually, accor

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

ing to the study.

The findings of this study were quiet similar to the results revealed by Harvard researchers earlier

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

in January 2004. The study was done on 125,000 people and found that men who drank 6 cups a day cut their diabetes risk

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

Following aspects would a

by half over 12 to 18 years, while women who drank the same amount of coffee had a 30 percent lower risk. Another resea

dd to the challenges in developing combination products:

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

ch by Dutch had also confirmed a similar effect.

A report published in Journal of The American Medical Association rev

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

aled a clear evidence for an inverse and graded association between coffee consumption and type-II diabetes independent

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

of other risk factors. Because the Finnish population drinks more coffee than other populations, it is possible to dete

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

mine the risk of diabetes at high levels of coffee consumption. The report also mentioned that the reasons for the appa

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

Professional from academic institutions, pharmaceutical industries, health care indust

ent beneficial effects remain unclear, although it was possible that chlorogenic acid in coffee may indirectly help reg

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

late blood glucose levels. Nevertheless, the report did stated that caffeine stimulates insulin secretion by the pancre

.

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

s has been well documented.

The American Heart Association has also said that studies looking at a direct link between

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

Companies that provide selfless information through particip

caffeine, coffee, and heart disease have produced conflicting results, but that 1 or 2 cups a day does not seem harmful

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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