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Rheumatoid arthritis is a disease that affects joints and may affect other systems in your body. As yet, there is no kn

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

own cure. But recent research means that people with rheumatoid arthritis can have relieving treatment that lessens the

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

Examples of combination products may in

pain and discomfort.

Rheumatoid arthritis affects approximately 3% of the population and effects 3 times more women th

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

an men. The disease usually develops between the ages of 25 to 50 but can occur really at any age. A similar type of ar

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

hritis affects children as well.

Rheumatoid arthritis may develop gradually or can start with an unexpected sudden att

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

Combination pro

ck. It is a chronic disease that may last a lifetime. Some people may often have times when the arthritis goes away, th

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

is is called a remission. These remissions can last weeks or even years.

What causes rheumatoid arthritis?

Although w

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

know a lot about what happens in rheumatoid arthritis, we do not know the underlying causes. Research has come to the

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

conclusion that triggering agents may cause the onset of the disease only in patients who have a tendency towards the d

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

sease. The triggering agent at fault is most likely a virus or bacteria.

If you have a close relative with rheumatoid

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

rthritis, the risk of you developing the disease is a possibility at some time in your life. Diet, stress, trauma, horm

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

Following aspects would a

ones and weather probably do not cause rheumatoid arthritis but these areas may affect the amount of discomfort and pai

dd to the challenges in developing combination products:

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

experienced.

Rheumatoid Arthritis – What Happens?

Rheumatoid arthritis results from the changes in your body’s immun

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

e system. No one quite understands why but when you have rheumatoid arthritis your body’s immune system attacks its own

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

organs and the tissues of the joints. This attack on your immune system makes many different things happen.

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

our joints and synovial membrane that lines them become inflamed

This causes too much fluid to be produced in

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

Professional from academic institutions, pharmaceutical industries, health care indust

your joints

The fluid and inflammation make your joints swollen and painful

If this keeps happenin

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

your cartilage and other soft tissue can be damaged, causing joint deformities

Other happenings in your b

.

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

ody when you have rheumatoid arthritis include:

anaemia
small swellings called nodules
s

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

Companies that provide selfless information through particip

elling around the eyes, blood vessels and heart

enlarged lymph glands

dry eyes and mouth

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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