Advice Pool - Health and Fitness

Several recent studies show that most cases of Type II diabetes can be prevented with th

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

e diabetic medications, metformin, Avandia or perhaps Actos (Lancet, September

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

Examples of combination products may in

29, 2006; Diabetes Care, Volume 29, 2006). An earlier study showed that lif

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

style changes were even more effective in preventing diabetes than drugs (Annals of

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

Pharmacotherapy, July 2004).

People most likely to develop diabetes have a family

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

Combination pro

history of diabetes, are overweight, and store fat primarily in the belly, rather than

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

the hips. They often have a thick neck, male pattern baldness, high blood levels of tr

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

glycerides and low levels of the good HDL cholesterol, and do not exercise. Pre-diabete

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

s is defined as having a fasting blood sugar greater than 100 but less than 125, a one

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

hour-after-eating blood sugar greater than 160 but less than 200, and an HBA1c greater t

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

han 5.7 but less than 6. (HBA1c is a blood test that measures how much sugar is stuck

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

Following aspects would a

on cells).

If pre-diabetics take medications used to treat diabetes, or change their li

dd to the challenges in developing combination products:

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

estyles, they markedly reduce their chances of going on to develop diabetes. Both the pr

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

evention and treatment of diabetes involves preventing blood sugar levels from rising to

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

high after meals. To do this, a person should avoid the foods that cause the highest

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

rises in blood sugar levels, such as those made from flour, those with added sugar, and

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

Professional from academic institutions, pharmaceutical industries, health care indust

sugar water found in fruit juices and many soft drinks. Other recommendations are to

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

lose weight, exercise, and eat fewer calories.

If you fit the description of a person a

.

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

risk for diabetes, check with your doctor and get a blood test called HBA1C. If the va

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

Companies that provide selfless information through particip

lue is greater than 5.6, you should start your diabetic prevention regimen immediately

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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