Advice Pool - Health and Fitness

How do you know when your back pain is due to strained muscles or overwork and when it is more serious? One usually learns that back pai

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

n is chronic if the pain lasts for more than six weeks and does not get better. A chronic condition is one in which the problem can be e

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

Examples of combination products may in

pected to remain over a period of time as opposed to an acute injury which can be expected to resolve within a few days or weeks. Disc h

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

rniation is a chronic problem that can cause very significant pain.

What is disc herniation? The gel-like substance that is found betwe

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

n the vertebrae is called a disc. The disc has a hard material on the outside but is soft on the inside. The vertebrae are the bony str

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

Combination pro

ctures in the spine. The main function of the disc is to absorb shock from movement of the body and to keep the vertebra separated and n

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

t touching one another. A disc can begin to degenerate when the outer, harder part of the disc is torn or otherwise damaged.

The dictio

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

ary defines herniation as “to protrude through an abnormal bodily opening so as to constitute a hernia.” When the outer shell of the dis

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

deteriorates the inner core pushes back into the spinal column, which is known as a herniated disc. This movement of the disc can actua

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

ly cause it to rub up against the spinal cord and surrounding nerves. This can put direct pressure on the nerve which can cause intense

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

pain throughout the body.

You will hear people refer to disc herniation with several different names including a “slipped disc.” Howeve

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

Following aspects would a

this is a misnomer because the disc cannot “slip,” due to the fact that it is stuck tightly between two vertebrae. Disc herniation may

dd to the challenges in developing combination products:

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

lso be called a prolapsed disc, ruptured disc, pinched nerve or bulging disc. A more clinical description is degenerative disc disease.

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

Symptoms vary among people from none to very severe. This will depend on the location of the herniated disc and the degree of damage.

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

ome symptoms that may occur along with the pain are tingling, numbness, spasms and muscle weakness. In more serious cases the problem ma

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

lead to paralysis. It is important that a physician be consulted whenever back pain is chronic or you suspect a herniated disc.

There

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

Professional from academic institutions, pharmaceutical industries, health care indust

re several things you can do to for treatment of a herniated disc:

1. Rest and keep motion to a minimum

2. Explore alternative therapie

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

such as acupuncture, massage and relaxation exercises

3. Physical therapy

4. Anti-inflammatory drugs and/or steroids as prescribed by

.

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

our physician

5. Surgery to correct the positioning of the disc

6. Disc replacement surgery

7. Pain management using a combination of

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

Companies that provide selfless information through particip

hese approaches

If you suspect a herniated disc, be sure to get a proper diagnosis and consider which treatment options are best for you

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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