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A diabetes diet should do three things; achieve ideal weight, maintain normal blood glucose levels, and limit foods that contribute to hear d

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

isease.

The proper diet can help someone with diabetes:

Achieve and maintain desirable weight. Many people with diabetes can control their

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

Examples of combination products may in

blood glucose by losing weight and keeping it off.

Maintain normal blood glucose levels.

Prevent heart and blood vessel diseases, condition

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

s that tend to occur in people with diabetes.

The guidelines for diabetes diet planning include the following:

Many experts, including the

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

American Diabetes Association, recommend that 50 to 60 percent of daily calories come from carbohydrates, 12 to 20 percent from protein, and

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

Combination pro

no more than 30 percent from fat.

Spacing meals throughout the day, instead of eating heavy meals once or twice a day, can help a person avo

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

id extremely high or low blood glucose levels.

The best way to lose weight is gradually: one or two pounds a week. Strict diets must never b

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 undertaken without the supervision of a doctor.

People with diabetes have twice the risk of developing heart disease as those without diab

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

etes, and high blood cholesterol levels raise the risk of heart disease. Losing weight and reducing intake of saturated fats and cholesterol,

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

in favor of unsaturated and monounsaturated fats, can help lower blood cholesterol.

For example, meats and dairy products are major sources

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

of saturated fats, which should be avoided; most vegetable oils are high in unsaturated fats, which are fine in limited amounts; and olive o

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

Following aspects would a

il is a good source of monounsaturated fat, the healthiest type of fat. Liver and other organ meats and egg yolks are particularly high in ch

dd to the challenges in developing combination products:

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

olesterol. A doctor or nutritionist can advise someone on this aspect of diet.

Studies show that foods with fiber, such as fruits, vegetable

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

s, peas, beans, and whole-grain breads and cereals may help lower blood glucose. A doctor or nutritionist can advise someone about adding fib

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

er to a diet.

Exchange lists are useful in planning a diabetes diet. They place foods with similar nutrients and calories into groups. With

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

the help of a nutritionist, the person plans the number of servings from each exchange list that he or she should eat throughout the day. Mor

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

Professional from academic institutions, pharmaceutical industries, health care indust

e information on exchange lists is available from nutritionists and from the American Diabetes Association.

Someone with diabetes can get as

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

sistance in the following ways: A doctor can recommend a local nutritionist or dietitian. The local American Diabetes Association, American 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

eart Association, and American Dietetic Association can provide names of qualified dietitians or nutritionists and information about diet pla

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

Companies that provide selfless information through particip

nning. Local diabetes centers at large medical clinics, hospitals, or medical universities usually have dietitians and nutritionists on staff

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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