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It is well known that diabetes as a disease is so harmful for human body that it brings about the downfall of many a vital human or

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

gan, kidneys being one of them. Kidney failure is one of the long term complications that can occur if diabetes is left undiagnosed

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

Examples of combination products may in

or untreated. In this article I will tell you how much damage diabetes can cause to your kidneys and what you can do to prevent it.

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

In order to determine whether you have a kidney problem, I would need to ask you a few questions. Do you feel a burning sensation

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

hen urinating? Is the color of your urine cloudy or bloody? Do you urinate frequently and are unable to hold any amount of urine in

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

Combination pro

your bladder? Do you often feel an urgent need to relieve yourself? Have you tested your urine for ketones? Are you suffering from

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

backache, chills, fever etc.? If your answer to all these questions is 'Yes' then you might be suffering from the early symptoms o

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

kidney damage. You should call your healthcare provider immediately if you are experiencing any of the above symptoms.

The factio

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

of our kidneys is manifold. Kidneys not only help in retaining the right amount of water within our body, it also filters out harm

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

ul wastes from our body, forming urea. This urea then passes from our body as urine. Those parts of the kidney that filter out wast

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

s can be damaged y diabetes. When the essential filtering parts of the kidney are damaged beyond repair we term it as kidney failur

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

Following aspects would a

e. Diabetes patients whose kidneys fail generally have two options to go for: either they need their blood to be filtered with the

dd to the challenges in developing combination products:

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

elp of a filtering machine (this treatment is known as dialysis) or have a kidney transplant which is more expensive.

Failed kidne

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

s cannot effectively filter out all wastes from our bodies. Most of the wastes products remain and build up within our body.

Obvio

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

sly, the only way to save your kidneys from such harmful damage is to take control of blood sugar levels. A protein known as glomer

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

li, which is essential to keep oneself healthy, begins to leak through the damaged parts of the kidney and pass on as urine. As you

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

Professional from academic institutions, pharmaceutical industries, health care indust

can see, a damaged kidney is not only unable to filter out most of the waste products from the body, it is also unable to prevent

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

he wastage of valuable proteins such as glomeruli and albumin. It doesn't get any worse than this!

So, are there are any ways to p

.

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

event kidney damage? There sure are! In the second part of this article, I will discuss the exact steps you need to take in order t

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

Companies that provide selfless information through particip

save your kidneys from irreparable damage. To learn more about diabetes kidneys, simply click on the link in my resource box below

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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