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Sciatica is the name of a type of leg pain and is fairly com

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

mon. It is usually caused when a bulging or ruptured disc pi

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

Examples of combination products may in

ches one of the nerves that goes down to the legs.

Often in

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

jections, epidurals, or nerve blocks are suggested therapies

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

and are performed using X-ray for visual guidance. The surg

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

Combination pro

on injects cortisone, a potent anti-inflammatory, around the

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

painful and inflamed nerve to relieve the symptoms.

For a

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

uptured disc (where a piece has broken off), an open, micros

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

opic surgery may be needed. When the disc is “bulging” or “p

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

rolapsed” but not broken off, research has shown that some p

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

rcutaneous (needle) procedures may work well.

With percutan

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

Following aspects would a

ous needle surgery, there is no incision and only a local an

dd to the challenges in developing combination products:

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

esthetic is required. The needle is positioned with the help

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

of X-ray. A laser is then used to remove a small portion of

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

he damaged disc through the needle. The procedure typically

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

takes 20 to 45 minutes, and hospitalization is not needed.

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

Professional from academic institutions, pharmaceutical industries, health care indust

he laser needle procedure will be successful 75 to 90 percen

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

of the time in good candidates. Surgery can be avoided if t

.

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

he pain is relieved. Common sense dictates that the least in

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

Companies that provide selfless information through particip

asive, and the least risky treatments, should be tried first

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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