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Advice Pool - What is Diabetic Neuropathy?
Every year millions of people around the world are affected by diabetes Along with the more normal symptoms
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
and problems diabetes is known for there are also additional conditions that not everyone may be aware 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
Examples of combination products may in
Diabetic neuropathy is one such condition that those with diabetes must be aware of.
The question many pe
The question many pe
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ople ask is what is diabetic neuropathy? In short it is a condition which affects the ability of the periph
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
eral nerves to function correctly. This usually occurs in the toes in feet first and can lead to numbness,
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ingling and painful burning sensations in the affected areas.
Diabetic neuropathy is a serious condition t
Diabetic neuropathy is a serious condition t
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
hat all diabetics need to be cognizant of. There are a number of serious problems that can arise as a resul
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 of having this condition. Because one of the major symptoms is a numbing of the feet those with diabetes
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
need to have a regular foot inspection schedules everyday. Any injury to the foot can go unnoticed until it
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
turns into a bigger problem. For instance even a small cut that goes untreated can become infected and tur
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
gangrenous, resulting in either part or all of the foot being amputated.
At the first signs of diabetic n
At the first signs of diabetic n
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
europathy it is important for the diabetic to seek a consultation with their doctor. Ignoring the problem i
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
s not an option as it can quickly lead to limb and life threatening problems. It is important that your doc
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
tor is knowledgeable in the treatment of diabetic neuropathy because while it is treatable there is not a c
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ure. Learning proper foot care and identifying potential problems is key to treating this condition.
It is
It is
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
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
also important to contact the American Diabetes Association and the Juvenile Diabetes Research Foundation f
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
or further information. These two organizations will be able to provide literature and strategies for deali
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ng with diabetic neuropathy. The more knowledge one has regarding this disorder the better prepared they wi
.
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
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
ll be to deal with all contingencies.
In order to effectively combat the problems brought about by diabeti
In order to effectively combat the problems brought about by diabeti
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
c neuropathy the diabetic must remain ever vigilant of the signs and symptoms that this condition can bring
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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