Advice Pool - Health and Fitness

Type 2 Diabetes is by far the most common type of the disease accounting for 90-95% of al

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

l cases. The American Diabetes Association (ADA) estimates that 21 million Americans have

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

Examples of combination products may in

diabetes and that only two thirds of them even know it. Type 2 starts in middle age or l

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

ater. It is growing so rapidly because of the epidemic in obesity not only in the US but

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

ll over the world. There is no cure but there is plenty you can do to prevent it and then

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

Combination pro

control it.

Type 2 is a chronic condition that affects the way your body metabolizes su

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

gar the main source of fuel. When people eat food, it is broken down into a sugar known 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

s glucose, which is then released into the blood where it is carried to cells inside the

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

ody. Insulin is made by the pancreas to help the cells use the glucose from the blood.

P

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

eople with Type 2 Diabetes have insulin resistance which prevents insulin from processing

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

glucose properly. Soon more and more insulin is produced to overcome the resistance. Dur

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

Following aspects would a

ing the later stages of the disease as the resistance increases, the blood glucose increa

dd to the challenges in developing combination products:

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

es to above safe levels, but the body can't use it properly and the body actually starves

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

for more energy.

If left untreated and again most people don't know they have it, disas

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

trous results are sure to come. It increases risk for eye, nerve, blood vessel, heart, an

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

d kidney problems.

Many people diagnosed with Type 2 are obese and have a sedentary life

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

Professional from academic institutions, pharmaceutical industries, health care indust

tyle. Just getting older is also a risk factor, because as we age our resistance to insul

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

in can rise too. 21 percent of people over 60 have diabetes-a scary statistic!!

The most

.

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

important thing to remember, if you are diagnosed with Type 2 diabetes is that it is pos

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

Companies that provide selfless information through particip

sible to control your diabetes instead of letting it control you. But it is in your hands

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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