E-Articles - Health and Fitness

As anyone who has -- or knows someone who has -- Rheumatoid Arthritis, it can prevent the sufferer from leading a normal life. It is a condition of unknown cause that can vary in intensity from a short, s

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

elf-limiting illness to a long term, progressively worsening illness. Initially, treatments are light, aiming to remedy joint stiffness and inflammation. In the chronic cases, the inflammation can become

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

Examples of combination products may in

orse, requiring a whole range of treatments including steroids, joint replacement and fusion ok bones. The joints of the body can become deformed and strength dwindles, leaving the sufferer unable to open

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

even a bottle of milk or turn on a tap. You have good days and you have bad days.

"You are what you eat" is a clich?, but very true. Certain foods are thought to exacerbate Rheumatoid Arthritis

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

for example, dairy produce. Rheumatoid arthritis occurs predominantly in developed countries where a large part of the diet is animal and the aforementioned dairy produce. Even if someone is only mildly

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

Combination pro

llergic to dairy, this can cause antioxidant levels to fall, antibodies are produced in response and these, for whatever reason, attack the joints. So keeping a diary of foods may help to pinpoint what tr

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

iggers the bad days.

So, if food seems to be the trigger, reducing dairy foods and increasing antioxidants in your diet may help. But how to get more antioxidants? The tastiest ways are probabl

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

to eat plenty of fresh vegetables and drink a few cups of green tea each day. Why is green tea better than 'normal' tea? The tea that most westerners are used to is black tea. Whilst that is a better for

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

you than coffee, it is not as beneficial as green tea. The reason? Black tea has been fermented; green tea has not, thus leaving the key chemicals intact.

But what evidence is there that green t

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

ea can actually benefit Arthritis sufferers? Studies in mice suggest that green tea antioxidants may have a powerful effect in reducing the incidence and severity of Rheumatoid Arthritis. Polyphenols (ant

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

oxidants found in green tea) possess much more potent antioxidant activity than well-known antioxidants such as vitamin C and vitamin E. A research team from Western Reserve University, Cleveland, Ohio ha

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

Following aspects would a

focused on the effect of these polyphenols in Rheumatoid arthritis. Mice studied by the Cleveland researchers were fed either plain water or water enriched with green tea polyphenols. The doses were abou

dd to the challenges in developing combination products:

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

t equivalent to a human drinking 3-4 cups of green tea per day. Each of the mice was then injected with collagen, making them vulnerable to a condition very similar to human Rheumatoid Arthritis. The stu

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

y indicated that the mice who had been given the green tea polyphenols "were significantly less susceptible to the development of collagen-induced arthritis, and if they developed arthritis, the disease w

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

s late in onset and mild in comparison to mice not given green tea polyphenols". (Proceedings of the National Academy of Sciences 1999;96:4524-4529).

There are other benefits too - in another st

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

udy in the US it has been shown that drinking at least one cup of green tea per day can reduce the risk of heart attack by 44%. This health benefit is thought to come from flavanoids, a type of antioxidan

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

Professional from academic institutions, pharmaceutical industries, health care indust

found in all types of tea. Flavanoids are thought to neutralise the effect of free radicals, highly reactive molecules that travel round the body causing damaging chemical reactions to cells, including t

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

ose in the heart tissues. A previous Dutch investigation of more than 800 men between 65 and 84 showed that drinking even more tea - between three and four cups a day - decreased risk of death from corona

.

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

ry heart disease by 58%. In 1991 there were just 153 studies on tea, while in 1998 there were 625 published papers. In a Japanese study, tea without sugar has been found to be good for teeth and gums. Tea

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

Companies that provide selfless information through particip

contains tannin fluoride which appears to help prevent plaque. "An increase of just one cup a day could prove invaluable in the fight against gum disease," said the British Dental Health Foundation

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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