Advice Pool - Health and Fitness

If you have already suffered from the effects of a kidney stone, you will be well aware of how painful it can be.

But what is a kidney stone

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 how does it form?

Firstly, what do our kidneys do?

Your kidneys are bean-shaped organs, each about the size of a small fist, located

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

Examples of combination products may in

ear the middle of your back, just below the rib cage. They act as very efficient trash collectors. Your kidneys process around 200 quarts of blood ea

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

h day and sift out about 2 quarts of waste products and extra water. This waste and extra water become urine, which flows to your bladder through tub

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

s called ureters. Your bladder stores urine until you go to the bathroom where you excrete it through your urethra.

The wastes cleaned from your blo

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

Combination pro

d by your kidneys come from the normal breakdown of active muscle movement and from the food you eat. Your body uses the food for energy and self-rep

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

air. After your body has taken what it needs from the food for energy and self-repair, the waste products are sent to the blood. If these wastes were

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

not removed by your kidneys, the wastes would build up in the blood and begin to seriously damage your body. Other functions of your kidneys include

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

elping to control blood pressure and to make red blood cells.

What then is a Kidney Stone?

It is a solid piece of material that

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

ay form in the kidney from waste substances in the urine.

A kidney stone, once formed may stay in the kidney or travel down the urinary tract. A sma

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

l kidney stone may pass all of the way out of the body causing very little pain, or even no pain at all.

A larger stone may become stuck in a ureter

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

Following aspects would a

, in the bladder, or in the urethra.[which is the tube leading from the bladder which allows you to urinate]. A problem kidney stone can block the fl

dd to the challenges in developing combination products:

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

w of urine and cause great pain.

The four major types of kidney stones:

the most common type of kidney stone contains calcium. While c

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

lcium is a normal, and very necessary, part of a healthy diet the calcium that is not used by the bones and muscles goes as a waste product to the ki

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

neys. Most of the time, the kidneys flush out this extra calcium in the urine. However at times, some calcium remains in the kidneys and eventually j

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

ins with other waste products to form a stone;

struvite stones may form after an infection in the urinary system. These stones contain

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

Professional from academic institutions, pharmaceutical industries, health care indust

the mineral magnesium, which may have come from your diet, and the waste product ammonia which has resulted from your body processes;

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

c acid stones may result if there is too much acid in your urine. If you tend to form uric acid stones, you may need to reduce the amount of meat you

.

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

eat.;

cystine stones are rare. Cystine is one of the building blocks that make up muscles, nerves, and other parts of the body. Cystine

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

Companies that provide selfless information through particip

an build up in the urine to form a stone. The disease that causes cystine kidney stones is genetically based, that is, it runs in families.

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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