Advice Pool - Health and Fitness

Diabetes is a metabolic disorder that reduces a person’s immunity. It can lead to heart disease, and it may also affect some organs of the body,

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

such as the eyes. Diabetes is, in fact, the cause of the most common form of blindness, a condition known as diabetic retinopathy.

Almost all

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

Examples of combination products may in

atients with Type 1 diabetes and 60 percent of patients with Type 2 diabetes who have had the disease for 15 years or longer, suffer from some d

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

gree of diabetic retinopathy.

Besides getting the risk of going blind, diabetics also have greater chances of getting cataracts at an earlier a

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

e, and glaucoma, a condition where a build-up of high pressure in the eyes causes the optic nerves to become damaged.

Diabetes damages the bloo

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

Combination pro

d vessels in the body causing various eye problems. Normally, our retinal vessels do not leak. But uncontrolled condition of diabetes might caus

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

a leakage of the blood vessels and also a swelling of the retina. Blockage of the vessels might also occur, resulting in a shortage of oxygen t

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

the eyes and the growth of new, abnormal vessels, which may cause bleeding, scarring, and even retinal detachment.

One of the common treatment

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

for diabetic retinopathy is laser photocoagulation that uses light to burn the retina. This helps reduce the swelling and leakage and improves

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

vision. In cases where the blood vessels in the eyes shut down, doctors will use laser surgery on larger areas of the eyes to reduce the lack of

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

oxygen within the retinal tissues. This also cuts off the stimulus for the development of new, abnormal vessels. But in the more advanced stages

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

Following aspects would a

of the condition, surgery might be required to remove the blood and scar tissues.

Laser and surgical treatments serve to stabilize a patient’s

dd to the challenges in developing combination products:

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

ondition but do not cure it totally. Patients typically regain about 50 percent of their sight; hence it is important that regular and annual ey

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

e screenings are necessary for early detection.

Diabetes can be asymptomatic, which means that some people can go for years without realizing t

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

at they have the disease if symptoms (excessive thirst, frequent trips to the toilet, skin or urine infections) do not surface.

They tend to di

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

cover their condition only after their vision has become blurred and diabetic retinopathy has already set in. About 21 percent of patients are f

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

Professional from academic institutions, pharmaceutical industries, health care indust

und to have retinopathy at the point of their diabetes diagnosis. Those with a family history of the condition are urged to go for regular healt

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

h checks as they are at a higher risk of getting the disease.

The key in preventing the onset of diabetes-related eye problems is to maintain h

.

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

althy blood glucose levels with regular medication and a strict diet. Diabetics should try utmost to cut sugar from their diet. Limit fruit to o

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

Companies that provide selfless information through particip

e portion per meal and avoid white flavor and carbohydrates like white rice and bread, and opt for unpolished rice and multi-grain bread instead

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 - Blindness Could Be Caused By Diabetes!

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