Advice Pool - Health and Fitness

In a time not too long ago, there lived a little girl named Lindsey. (Real story.)

She was born on the pale s

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

ide of health and never seemed to get better. At six she was diagnosed with juvenile diabetes.

Then began the

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

Examples of combination products may in

scramble to save her life. Heavy doses of insulin. Seventeen different drugs.

But nothing worked. Gradually

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

her listless body began to shut down. First the bladder. Then the kidneys. Then the liver.

Her mother, in a f

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

rantic effort to buy time, wanted to donate a kidney. But the doctors refused. It was too late. The damage too

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

Combination pro

great.

Lindsey went home to die.

But then someone suggested giving her sugar. At first, Lindsey’s mother wa

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

s horrified. But then she became convinced enough to add eight simple sugars to her daughter’s diet.

Nothing

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

happened...at first. It took time. But then improvement began to shine from behind Lindsey’s wasted face.

Gra

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

dually, her organs started functioning again. The prescription drugs were dropped. Her insulin requirements we

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

re cut in half.

Today, Lindsey is an energetic young girl of 12. Loves sports. And is trying out for cheerlea

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

ding.

Did the simple sugars heal her?

No. Simple sugars have no healing power of their own. Yet recent Nobel

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

Following aspects would a

Prize winning discoveries in medicine confirmed that they are essential for the functioning of human cells. A

dd to the challenges in developing combination products:

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

nd it is the cells that perform the healing. Not only do they heal but, as in Lindsey’s case, the damage cause

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

d by the disease is often reversed.

Is diabetes the only disease affected by these simple sugars?

No. There

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

are thousands of testimonials from people with life debilitating and life threatening diseases that have been

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

helped. Cancer...MS...Fibromyalgia...arthritis...and that’s just the beginning of a long list.

So why haven’t

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

Professional from academic institutions, pharmaceutical industries, health care indust

you heard about this?

The Science of Simple Sugars is relatively new. Plus the sugars are classified as ‘foo

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

d’ which tends to place them below the radar of most doctors.

This means you may have to check out the scienc

.

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

e on your own. There are a number of resources available.

It will eventually become standard medical treatmen

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

Companies that provide selfless information through particip

t. But until then, many people will suffer and even die because of the lack of knowledge. Don’t be one of them

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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A violin can be an intimidating musical instrument – it's beautiful to look at and listen to but a violin requires an extraordinary amount of education and discipline to be played properly. If you’re thinking of taking violin lessons but feel anxious about it, familiarize yourself with the instrument. Here’s an introduction to the art of playing the violin.

This one is for the newbies out there. Don't feel bad. I didn't mean that as an insult. We were all newbies once.

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Advice Pool - Diabetes... Sweet Story of Healing

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