Advice Pool - Health and Fitness

People always associate sugar with diabetes. Perhaps it is partly because of the fact that patients with diabetes are monitored

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

with regular measurement of their blood sugar. As you know, diabetes causes one’s body not to produce or properly use insulin. I

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

Examples of combination products may in

nsulin is a hormone needed to convert sugar, starches and other food into energy needed for daily life.

Oscar- winning actress

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

Halle Berry has been living with diabetes for more than 15 years. In 1989, Miss Berry was diagnosed with diabetes and has since

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

hen been active in raising awareness about the disease. She admits that she is very strict with her diet - chicken, fish, vegeta

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

Combination pro

bles, brown rice, and tabbouleh (a Middle Eastern salad of wheat, parsley and tomatoes). In addition, she exercises regularly, a

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

nd it is this combination that really keeps her healthy. To have diabetes under control, it is also important to know what and w

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

en you eat.

Experts do suggest diabetics should control the amount of carbohydrates they eat. They must also eat regular meals

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

to avoid fluctuations in the blood sugar levels. Eating only a meal a day is not healthy at all, instead diabetics should eat sm

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

all and frequent meals.

Diabetics are advised to consult a nutritionist to work out a food plan that is balanced and nutritious

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

For example, substituting simple carbohydrates like white rice and bread with more complex ones such as brown rice and wholemea

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

Following aspects would a

l bread can make a difference.

Foods with low glycemic index (GI) are better for diabetics. The GI refers to a food’s ability t

dd to the challenges in developing combination products:

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

o raise blood sugar to a particular level within a given period of time. Low GI foods include oats, barley, rye grain, dried bea

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

ns, lentils, apricots, and peanuts, while potatoes have a high GI. But this does not mean that all foods with a high GI should s

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

rictly be avoided for diabetics.

There is also misconception that diabetics should avoid all sugar. In fact, carbohydrates whic

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

h include sugar should account for 50 to 60 percent of their total energy intake. The carbohydrates should be eaten in 3 main me

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

Professional from academic institutions, pharmaceutical industries, health care indust

als and 3 small snacks. The amount of carbohydrate food should be consistent at each meal.

Bear in mind that keeping blood suga

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

under control is ultimately about balancing the diet with insulin, oral medications and exercise. If one has any difficulty in

.

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

doing this should seek help from doctors, hospitals, or pharmacists where diabetes management programs are offered. Diabetics sh

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

Companies that provide selfless information through particip

ould not overlook this because they could easily become victims of heart disease if their conditions are not properly controlled

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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