Your Space - Health and Fitness

Back in the 1950's and 60's most people didn't rate diabetes as a major problem. Back then, all the focus was on dealing with more prominent diseases such as polio and tuberculosis

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

. If diabetes was thought about, it was more in the context of cutting out sugar in your coffee, rather than as a serious threat to your eyesight or your life.

That's all changing

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

Examples of combination products may in

. It's not too much to say that diabetes is now reaching epidemic levels in most of the western world. According to the American Diabetes Association there are over 20 million diab

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

etics in the United States alone, with a staggering one third undiagnosed. It's also going to get a lot worse with another 41 million Americans already showing pre-diabetic signs.

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

Diabetes is a disease that mostly affects blood vessels and in its extreme forms can lead to serious heart disease, stroke and kidney damage. Clearly these life threatening diabet

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

Combination pro

ic vascular diseases deserve priority attention, but high on the critical list for diabetics is the risk of serious eye disease and loss of vision.

Vision is one of our most criti

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

cal senses and in this "need for speed" information era, over 70% of our sensory information comes through our eyes. According to the American Academy of Ophthalmology, diabetics a

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

re 25 times more likely to lose vision than those who are not diabetic. With diabetes already being the number one cause of blindness in the United States, it's no wonder eye care

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

professionals are predicting a devastating increase in vision loss as the diabetic epidemic grows alarmingly.

Newly diagnosed diabetics often have nothing more than minor vision f

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

luctuations which settle when blood sugar levels improve with treatment. Early on it's easy to believe everything is fine. After some years though, continuing high blood sugar can

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

gradually damage the blood vessels at the back of the eye in the retina. This causes a problem called diabetic retinopathy and the longer you have diabetes the more likely you are

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

Following aspects would a

to have retinopathy. The risk increases further when there is poor control of blood sugar levels. More than 70% of diabetics develop some changes in their eyes within 15 years of d

dd to the challenges in developing combination products:

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

iagnosis.

Retinopathy is graded as Non-proliferative or Proliferative. Non-proliferative retinopathy is the common milder form, where small retinal blood vessels break and leak. T

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

here may be some mild retinal swelling but it rarely requires treatment unless it causes hazy central vision or straight lines appear bent.

Proliferative retinopathy is the less c

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

ommon, but more serious form where new blood vessels grow abnormally within the retina. If these vessel scar or bleed they can lead to potentially serious vision loss including bli

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

ndness. Early laser treatment can seal leaking vessels and slow the progress of diabetic retinopathy, but can't reverse existing vision loss.

For now, there is no "magic pill" to

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

Professional from academic institutions, pharmaceutical industries, health care indust

eliminate the risk of diabetic eye damage, but you can do two important things to help prevent the more serious complications. Poor blood sugar control is one of the main causes of

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

serious diabetic retinopathy. The critical first step is making sure you stabilize and control your blood sugar with a healthy diet and regular exercise. The second step is to mak

.

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 sure you have a yearly diabetic eye examination. An experienced eye care professional can pick up subtle diabetic eye changes long before you notice any vision change, and more i

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

Companies that provide selfless information through particip

mportantly, early enough to do some good.

If you or your family is affected by this rising sign of diabetes: take action now to reduce your risk of vision loss. Don't be a victim!

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.yourspace.org.ua/article/240366/yourspace-Diabetes--Two-Steps-You-Must-Take-to-Avoid-Vision-Loss.html">Diabetes - Two Steps You Must Take to Avoid Vision Loss</a>

BB link (for phorums):
[url=http://www.yourspace.org.ua/article/240366/yourspace-Diabetes--Two-Steps-You-Must-Take-to-Avoid-Vision-Loss.html]Diabetes - Two Steps You Must Take to Avoid Vision Loss[/url]

It sometimes gets frustrating wading through all the modeling websites to find an agency to help launch your career. Here are some ways you can find a model agency including many of the top NY major markets.

Generating your own content for a website or information product is NOT easy. Yet, as an infopreneur, you will often be called upon to come up with valuable information for your audience.

Here are some questions to ask yourself to determine whether you are ready to refinance or not.

Tags

Links

Your Space - Diabetes - Two Steps You Must Take to Avoid Vision Loss

Related Articles: