Advice Pool - Health and Fitness

One of the concerning things about having diabetes is the risk of complications. Lit

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

tle is said about these - but they seem to be mentioned at regular hospital appointme

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

Examples of combination products may in

ts - and seem to be the inevitable result of poor blood glucose control.

Of these co

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

plications, one that seems most scary because there can be few visible warning 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

s the loss of eyesight that can occur. In fact, statistics show that the risk of goi

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

Combination pro

g blind is twenty five times higher for a diabetic than for a similarly healthy perso

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

.

Diabetic Retinopathy

With more than half diabetics experiencing some degr

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

e of retinopathy, or eye disease, this is clearly a serious concern and health risk.

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

Retinopathy refers to the damage to the blood vessels at the back of the retina.

Unt

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

l recently it wasn't easy to see this damage occurring, but thanks to new technology

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

t's possible to carry out a regular scan of the eyes to spot early signs of damage.

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

Following aspects would a

If caught at this early stage, laser surgery can help retain vision and reduce the ri

dd to the challenges in developing combination products:

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

k of permanent damage.

Near Normal Blood Sugar Levels

Studies have shown th

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

t people whose levels stay close to normal levels are less likely to experience compl

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

cations, not only for the eyes, but also the other risk factors.

This is why it's so

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

important to work with your health care team and to consider new options that are ava

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

Professional from academic institutions, pharmaceutical industries, health care indust

lable to help manage your levels.

For some this may be increased injections, for oth

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

r trying an insulin pump, whilst for others simply monitoring levels more frequently

.

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

ay help improve the management of their diabetes.

Do keep working at improving your

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

Companies that provide selfless information through particip

ontrol - as it will make a positive difference to your long term health and wellbeing

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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Advice Pool - Diabetes Eye Complications-and How You Can Avoid Them

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