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Diabetic Neuropathy is nerve damage caused by poor blood circulation that is a consequence of diabetes. This means that any nerve within the body can be damaged and lead to a ma

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

lfunction of that nerve or group of nerves. As nerves and the nervous system control and regulate many of the bodies vital organs and everyday functions this means that signs 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

diabetic neuropathy can manifest anywhere in the body. This article will pinpoint common symptoms and highlight ways to prevent and treat diabetic Neuropathy.

Diabetic Neuropa

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

thy is classified into four types. The types commonly describe the nerves affected and their related body areas.

Peripheral Neuropathy concerns the extremities of the body - th

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

e feet, hands, legs and arms.

Autonomic Neuropathy applies to the autonomic nervous system which controls the everyday functioning of the heart, stomach, urinary tract and othe

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

Combination pro

r body functions.

Proximal neuropathy concerns the thighs, buttocks and hips.

Focal neuropathy is concerned with specific nerves or groups of nerves that appear to 'flare up'

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

suddenly causing pain. Focal neuropathy can occur anywhere in the body and effectively means focused or specific nerve problems.

Each of these types of neuropathy have differen

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

t signs.

The most common form of neuropathy is peripheral neuropathy and primarily concerns the feet and hands. Common signs of diabetic neuropathy in the feet are numbness or

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

insensitivity to pain. If your feet are constantly feeling 'pins and needles' then you should see a doctor.

The feet are also more prone to cuts, bruises and infections because

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

the nerves do not communicate damage or pain to the body. Careful monitoring and care of the feet is a must for diabetics.

Hands are not as prone to nerve damage problems as f

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

eet because they are often uncovered and are easier to monitor and care for but they can still be susceptible to cuts and bruises and can lose sensitivity.

Autonomic neuropathy

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

Following aspects would a

commonly causes stomach problems. This could mean that food is not processed effectively which may lead to constipation, cramps or bloating. The autonomic nervous system also c

dd to the challenges in developing combination products:

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

ontrols the urinary tract which could lead to urinary tract infections or incontinence.

The autonomic nervous system controls the respiratory and cardiovascular systems too, so

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

problems with blood pressure and circulation can occur however these are often hard to detect for the individual and can be caused by other diseases other than diabetic neuropa

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

thy.

Proximal neuropathy applies to the hips, buttocks and legs. Commonly there will be pain in these areas and weakness that may make it hard to move from a sitting position t

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

o standing without help. Proximal neuropathy is often a consequence of long term diabetes and other symptoms of peripheral neuropathy are likely to exist beforehand.

Focal neur

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

Professional from academic institutions, pharmaceutical industries, health care indust

opathy is a sudden bout of pain in a localized area. This is a consequence of a group of nerves malfunctioning. The pain can be anywhere in the body but is often in the head or

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

torso regions. The pain will eventually recede over a few days to weeks.

The best way to treat diabetic neuropathy is to try to prevent it. This means maintaining blood sugar l

.

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

evels at a normal rate as often as possible. The more that the blood sugar level is normal the less chance for it to damage the nerves. This means eating healthy and sugar free

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

Companies that provide selfless information through particip

foods. It also requires regular exercise. For relief from the pain, doctors will often determine the area affected by the neuropathy and then prescribe the appropriate analgesic

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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