Advice Pool - Health and Fitness

The serious and dangerous nature of diabetes can often lead to other equally serious problems, such as a diabetes related nerve diseas

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

e called diabetic neuropathy. This disease develops as a result of having high blood glucose levels for 10 years or more.

The effec

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

Examples of combination products may in

t of this nerve damage is a slow down of a person's nerve conduction velocity (NCV). Nerve conduction velocity refers to the speed a

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

t which nervous impulses travel down a nerve fiber. Unfortunately, a person experiencing slow NCV can go a long time before showing a

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

ny symptoms. The only way for a person to see if they are affected by this is to take a test that will show the speed of their NCV.

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

Combination pro

This is the only way to diagnose neuropathy in diabetics who show no symptoms of nerve damage. Should the patient's test show a slowi

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

ng of their NCV, medication can be provided that, in many cases, will help improve their nerve damage symptoms.

Who is most susceptib

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

le to diabetic neuropathy? This disease is prevalent in both men and women aged 40 and over. This illness also tends to affect peop

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

le who are taller than average. In all probability, this is due to the fact that by being taller they have longer nerve fibers which

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

can damage more easily.

Testing Your Nerve Functions

Your doctor will be able to test the function of your nerves to determine wheth

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

r or not you have nerve damage as a result of diabetic neuropathy. Different nerve fibers are believed to be responsible for differen

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

Following aspects would a

t kinds of sensations. Your doctor can test, and create an analysis of the connections between the sensations and your nerves. The s

dd to the challenges in developing combination products:

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

ensations are those of touch, temperature, vibration, and light.

1. Vibration Testing: This is a rather simple test that can be ini

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

tiated with the use of a tuning fork. Doctors prefer to utilize vibration testing to bring out any abnormalities in the larger nerve

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

fibers of the body.

2. Temperature Testing: Temperature testing is very important when determining the body's smaller nerve fiber s

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

tatus. Knowing the status of these smaller fibers is extremely important. Should the smaller fibers be damaged, it is then possible

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

Professional from academic institutions, pharmaceutical industries, health care indust

for the patient to lose their ability to feel extremely hot temperatures such as boiling water.

3. Light Touch Testing: Light touc

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

h methods allow doctors to determine which, if any, large fibers are damaged. The body's larger nerve fibers sense anything that touc

.

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

hes the skin. They then send signals to our brain alerting us that we are experiencing a sensation. Someone with good health, witho

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

Companies that provide selfless information through particip

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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Advice Pool - Testing For Diabetic Neuropathy (Nerve Damage)

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