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Carpal tunnel syndrome is a common nerve entrapment disorder that causes significant impairment and disability, aff

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

ecting millions of Americans each year.

There are a variety of uncomfortable symptoms associated with the disorder

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

Examples of combination products may in

, but the most common clinical features involve pain, numbness, paresthesia (pins and needles) and tingling in the

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

thumbs, first two fingers and sometimes one-half of the ringer fingers. In more severe cases, pain travels from the

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

median nerve up the arm, creating referred pain and dysfunction throughout the forearm, shoulder, upper back and n

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

Combination pro

eck.

Despite decades of research, the etiology and pathophysiology of carpal tunnel syndrome are not well understo

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

od by many physicians and therapists, although its origin in most cases, aside from disease, is a result of muscle

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

imbalance in the upper extremity. Indeed, research shows that several factors make significant contributions 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

disorder including heredity (genes), environment (workplace stress), and illness (diabetes, renal failure). Althou

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

gh some of these things are unavoidable, there are still many easy, effective ways to prevent carpal tunnel syndrom

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

e.

Modifications to the home and workplace are often a first resort. Therapeutic chairs, keyboards, computer mouse

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

Following aspects would a

, wrist rests and wrist braces and splints are common options, although relief is often short-term. For long-term r

dd to the challenges in developing combination products:

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

elief, it is recommended that ergonomic products in combination with performing active stretches and exercises can

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

do a good deal to eliminate pain and to promote muscle balance with and around the carpal tunnel. This in turn reli

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

eves pressure on the median nerve and alleviates the disabling symptoms associated with carpal tunnel syndrome.

Th

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 best way to prevent carpal tunnel syndrome is to implement preventative measures, reduce unnecessary stress and s

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

Professional from academic institutions, pharmaceutical industries, health care indust

train to the hands and wrists and keeping physically fit and muscles balanced in order to keep carpal tunnel syndro

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

me and the other many repetitive strain injuries at bay. By exercising the muscles in the hand, wrist, forearm and

.

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

shoulder so as to promote optimal muscle balance, one can do a great deal to prevent carpal tunnel syndrome from o

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

Companies that provide selfless information through particip

ccurring.

Don’t wait until disability sets in. Take preventative measures to remain healthy, strong and pain-free

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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