I Advice - Health and Fitness

What is it?

Degenerative disc disease is a condition where the intervertebral discs change or deteriorate as we all age.

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

Everyone over the age of 18, will be subject to some sort of degenerative changes in their spine. With our discs, these

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

Examples of combination products may in

changes are somewhat different.

First we need to understand what the disc is and what it does. Our intervertebral discs

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

re located between each vertebra throughout our back. They are made up of a gel-like nucleus (nucleus pulposus) in the mi

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

ddle, and a strong outer layer (annulus fibrosus) that contains the nucleus, like a jelly donut. The discs start out at a

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

Combination pro

out 80% water when we are young. Since the disc is flexible, like a tough water balloon, it allows movement throughout 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

e spine, cushion, and spacing between each vertebra. However, as we age, these discs loose their hydration; making them l

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

ess flexible, less tolerant to motion, and decreased in height. All of these changes make the back more susceptible to in

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

ury or painful conditions.

Even though the discs degenerate as we age, when DDD is the cause of pain, it occurs when we

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

are younger, between the ages of 30 and 55. Once we are older, after 55, the discs are no longer a likely cause of pain.

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

hey lose their hydration and become more rigid and tough. Other risk factors can also increase your chance of developing

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

Following aspects would a

this condition such as smoking. So, if you are a sufferer of degenerative disc disease pain now, don’t worry that your pa

dd to the challenges in developing combination products:

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

in will continually get worse. In fact, your pain should get better the older you get.

What can you do? However, there

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

ay be some benefit found now through physical therapy. We can utilize many manual techniques, exercises, and modalities f

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

or pain relief. Walking swimming and bicycling are great ways to exercise if this condition affects you. Depending on wha

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

your symptoms are, specific exercise programs can be established to help you limit pain and return to work or the hobbie

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

Professional from academic institutions, pharmaceutical industries, health care indust

s you like to do in your free time.

The web address below gives a good illustration of what DDD is. Simply click on the

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

spine button, and then select degenerative disc disease and the animation will show you the progression of the condition.

.

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

http://www.understandspinesurgery.com/understand_problem.asp

Contact your physician if you are having back pain that is

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

Companies that provide selfless information through particip

not getting better on its own. If physical therapy is recommended, please choose Excel Physical Therapy. www.ExcelPT.co

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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