Advice Pool - Health and Fitness

Coffee has been a drink that people consume everyday, especially during breakfast. There are many negative reports on consuming coffee mainly due to

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

its caffeine. A study reported in the Archives of Internal medicine that there is a link between drinking coffee and a reduced risk of developing Typ

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

Examples of combination products may in

2 diabetes. Nevertheless, it is still not clear that whether the protective effect is due caffeine or other ingredients presented in coffee.

Diabet

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

s has been considered a risk factor of heart disease, and Type 2 diabetes develops when pancreas does not make enough insulin or when insulin cannot

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

e used by the body properly. Insulin is a hormone that converts sugars into energy. This form of diabetes is commonly found among people aged 40 and

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

Combination pro

bove, especially those overweight and physically inactive.

The study, conducted by the University of Minnesota, examined over 28,000 postmenopausal

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

women over a period of 11 years (1986 -1997). Women who drank more than 6 cups of coffee per day were less likely to be diagnosed with diabetes. Thos

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

who drank decaffeinated coffee showed a further reduced risk.

Questions were answered by these women about risk factors for diabetes, and details g

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

ven about their lifestyle and beverage consumption (including regular and decaffeinated coffee). After adjusting the data for other risk factors for

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

iabetes, it was found that women who drank more than 6 cups of any type of coffee daily were 22 percent less likely to be diagnosed with diabetes tha

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

non-coffee drinkers. Those who drank more than 6 cups of decaffeinated coffee per day had a 33-percent reduced risk.

The overall intake of caffeine

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

Following aspects would a

did not appear to be related to diabetes risk, suggesting that another ingredient in coffee might have contributed to the effect. The researchers su

dd to the challenges in developing combination products:

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

gested that magnesium, and other minerals and nutrients found in coffee bean such as polyphenols and antioxidants, may be responsible for this benefi

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

ial effect. However, further studies are required to ascertain this.

Other experts expressed some concerns about this study. Firstly, the participan

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

s were only limited to postmenopausal women and so are not representative of the population. Secondly, there is no objective measure to ensure that t

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 reported diet or incidence of diabetes were accurate because data were collected from self-administrative questionnaires. Thirdly, there are many k

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

Professional from academic institutions, pharmaceutical industries, health care indust

inds of foods containing hundreds of different phytochemicals and antioxidants. It may not be appropriate to simply rely on any single food to obtain

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

these nutrients. Finally, taking too much coffee can cause side effects. More than 3 cups of coffee a day can cause nervousness, stomach distress, in

.

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

omnia, and for some people, irregular heartbeat.

While awaiting further research confirmation about the beneficial effect of drinking coffee, people

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

Companies that provide selfless information through particip

with diabetes, however, still need to maintain healthy eating habits, regular physical activity, and more importantly, maintain a healthy body weight

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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