Advice Pool - Health and Fitness

For the diabetic maintaining their blood sugar level in the normal range is key to successfully managing their disease. Wit

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

hout proper blood glucose control the diabetic risks a variety of disorders and complications that are caused by high blood

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

Examples of combination products may in

sugar levels. Left untreated for a long period of time diabetes can become a life threatening illness.

When first diagnos

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

ed a doctor is looking for blood sugar levels within a certain range. There are three tests that can be used in diagnosing

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. These tests all require a blood draw and if the test comes back positive then that diagnosis must be confirmed on

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

Combination pro

a following day using one of the three tests.

The three tests that can be used to diagnose diabetes and blood sugar levels

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

that are looked for as recommended by the American Diabetes Association are:

• Casual plasma glucose level at or above 20

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

0 mg/dL. This is in addition to showing symptoms of diabetes. The casual test can be taken anytime of the day regardless of

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

the last time the person being tested ate.

• The fasting plasma glucose test is done at least eight hours after the perso

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

n has had their last intake of calories. The criteria for a positive result with this test are a plasma glucose greater the

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

126 mg/dL.

• The two hour oral glucose tolerance test. This test is done by the patient drinking a glucose solution conta

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

Following aspects would a

ining 75 anhydrous glucose dissolved in water. Blood is drawn two hours after drinking the solution and a positive result i

dd to the challenges in developing combination products:

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

s a plasma glucose level greater than 200 mg/dL.

Once the diagnosis of diabetes is made it is important for the diabetic t

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

o work to maintain their blood sugar level within a certain range. This is done through self monitoring of blood glucose us

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

ing a blood glucose monitor. Doing so will allow diabetics to monitor and control metabolic control of their disease and le

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

sen the risk of hypo or hyperglycemia, both of which can have negative risks.

The diabetic blood sugar level that those wi

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

Professional from academic institutions, pharmaceutical industries, health care indust

th diabetes should try and maintain is between 70 to 120 mg/dL either before a meal, like breakfast, or four to five hours

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

after their last meal or snack. Blood sugar will go up after any meal or snack and ideally it should drop to under 200 mg/d

.

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

L about two hours after that meal.

By keeping tight blood sugar control the diabetic can live a long and healthy life and

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

Companies that provide selfless information through particip

lower their risk for the many complications that include vision degradation, kidney disease, nerve damage and heart disease

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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