Advice Pool - Health and Fitness

A complication that all people with diabetes need to be aware of and on the lookout for is diabetic neuropathy. This is a disorder of the peripher

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

al nerves, which are the nerves in the outermost portions of the body (feet, hands, etc.). Recognizing the symptoms of diabetic neuropathy are of

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

Examples of combination products may in

ajor importance because to miss them can have life altering or even threatening affects.

Diabetic neuropathy is caused by the walls of the blood

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

essels that supply the nerves becoming thicker. The end result of this is less nutrients are unable to get to the nerves as well as a demyelinizat

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

on (destruction of the myelin sheath that protects nerves) of the Schwann cells that surround and insulate the nerves. This slows the ability of t

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

Combination pro

e nerves to conduct impulses back to the brain. Sorbitol also forms and accumulates in the Schwann cells causing further nerve conduction impairme

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.

There are two forms of neuropathies that can form with diabetes; polynueropathies and mononeuropathies. Polynueropathies are the most common i

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

those with diabetes and is a bilateral sensory disorder. The symptoms for this form of diabetic neuropathy are most common in the toes and feet a

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

d normally appear there first. The finger and hands can also be affected but this usually occurs during the later stages of the disease. Where the

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

symptoms appear will depend on what nerves fibers are affected.

The symptoms can differ among individuals and is dependent on the amount of damag

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

done to the nerves. It is a disorder that will get progressively worse if the diabetes is not properly managed. The first signs will normally be

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

Following aspects would a

a subjective change in sensation in the extremities that can include numbness and tingling.

Other symptoms can include an aching pain, a burning

dd to the challenges in developing combination products:

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

r shooting sensation, or feeling like you have cold feet. As the neuropathy progresses the symptoms can include impaired sensations of pain, touch

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

temperature, vibration, and two-point discrimination. The only way to treat polyneuropathy is through management of the diabetes itself.

Mononeu

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

opathies are isolated events that affect single nerves. The symptoms of this form of neuropathy are entirely dependent on which nerve is affected.

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

They can affect the oculomotor nerve which can lead to headache, eye pains and an inability to move the eye in any direction.

Another symptom of

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

Professional from academic institutions, pharmaceutical industries, health care indust

ononeuropathies is Radiculopathy which is characterized by pain that seems to radiate from the spine to extend outward to cause symptoms away from

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

the source of the spinal nerve root irritation. It is thought to be caused by an inadequate blood supply to the spinal nerve roots.

All diabetics

.

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

whether type 1 or type 2, need to be aware of the symptoms of diabetic neuropathy. The sooner it is brought to the attention of the diabetics hea

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

Companies that provide selfless information through particip

th care providers the sooner it can be managed through proper lifestyle choices that are centered on diet, exercise, and proper medical management

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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