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Rheumatoid Arthritis (RA), is one of the most debilitating of all 100 or so forms of the disease, causing joints to ache and throb and eventually become deform

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

ed. Rheumatoid Arthritis can make simple things like opening a jar or taking a walk excruciating for sufferers.

Unlike osteoarthritis, which is caused by wear

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

Examples of combination products may in

and tear on the joints, RA is an inflammatory condition. Its exact cause is unknown, but researchers believe that it is the caused when the body's immune syst

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

m attacks the tissue that lines the joints.

Who gets Rheumatoid Arthritis?
Women between the ages of 20 and 50 years of age, fall victim to this

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

debilitating disease two to three times more than men. Statistics show that no one is immune from it, however. Even children and the elderly have been diagno

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

Combination pro

ed. To date, there is no cure for rheumatoid arthritis, but treatments are being used to help sufferers protect joint damage in order to live more productive

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

ives.

The Symptoms:
The signs and symptoms of rheumatoid arthritis may come and go over time, according to Mayo Clinic experts, and may include:

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

-Pain and swelling of the joints, especially in the hands and feet.
-Generalized aching or feelings of stiffness of the joints and muscles.
-Loss of

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

otion.
-Loss of strength in muscles attached to the affected joints.
-Fatigue, which can be severe during a flare-up.
-Low-grade fever.
-De

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

ormity of the joints.
-General sense of not feeling well.

Rheumatoid arthritis usually causes pain in several joints at the same time. In its early s

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

ages, the joints of the wrists, hands, feet and knees are most affected, followed by pain in the shoulders, elbows, hips, jaw and neck as the disease progresse

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

Following aspects would a

s.

Small lumps, called rheumatoid nodules, are also common under the skin of the elbows, hands, feet and Achilles tendons during outbreaks. They can be as sm

dd to the challenges in developing combination products:

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

ll as a pea, or as large as a walnut, and generally aren’t painful.

Considered a chronic disease, rheumatoid arthritis features severe flare-ups featuring sev

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

re swelling, pain and weakness, followed by days, weeks or months of normalcy.

What Causes Rheumatoid Arthritis?
Although a specific cause is not

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

known, some researchers suspect that rheumatoid arthritis is triggered by a virus or bacterium infection in some people. Hormones are also being researched a

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

a development factor.

Risk Factors:
With no known cause, it’s hard to know for sure who will get RA, but some risk factors may include:

-Age. T

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

Professional from academic institutions, pharmaceutical industries, health care indust

e risk of getting rheumatoid arthritis seems to increase with age, until age 80, where it suddenly decreases.

-Sex. Females are more likely to contract RA th

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

en men.

-Viral Exposure. Being exposed to an infection, possibly a virus or bacterium that may trigger rheumatoid arthritis.

-Genes. Inheriting specific gene

.

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

may make some people more susceptible.

When To See A Doctor:
Persistent discomfort and swelling in multiple joints on both sides of the body may

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

Companies that provide selfless information through particip

e a sign that it’s time to seek medical treatment. Your doctor can work with you to develop a pain management and treatment plan for your rheumatoid arthritis

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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