Advice Pool - Health and Fitness

Currently there is no cure for Diabetes, although researchers are making strides in the field every day. However, Type 1 and Type 2 diabetes can be managed su

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

ccessfully by following a proper diet, getting regular exercise and, in some cases, using diabetes medication.

Diabetes Diet

Treatment of diabetes almost al

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

Examples of combination products may in

ays begins by following a diabetes diet designed to control blood glucose levels. Generally speaking, a healthy diet of a diabetic is a healthy diet for non-d

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

iabetics: 40 to 60 percent carbohydrates, 20 percent protein and 30 percent or less fat. Avoidance of excess consumption of sugar is also an important part 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

a diabetes diet. Diabetics don’t have to avoid sugar entirely, but need to incorporate it as part of a balanced diet, being careful not to add sugar to foods.

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

Combination pro

At each meal, diabetics can eat two to five carbohydrate servings, one protein serving and a small amount of fat. Following are general guidelines on what ty

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

pes of food to incorporate and types of food to avoid. A dietician or doctor can provide a balanced diabetes diet plan to follow.

Carbohydrates make up the 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

lance of the diet, and include fruits, vegetables, dairy, beans and starches (such as bread and rice). Reach for fresh fruit. Eat vegetables that are fresh, c

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

nned or frozen. Choose bread that’s high in fiber and low in sugar. Avoid canned fruit, dried fruit or fruit juices, all of which have excess sugar added.

Pr

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

otein sources include meat, poultry, dairy products, fish and beans. Eat more fish and chicken than red meat and reach for low-fat or fat-free dairy products.

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

Avoid eating poultry skin and excess fat on cuts of meat.

Fat is necessary for the body, but should be used in moderation. Fat is in dairy and meat products,

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

Following aspects would a

and the butter, margarine and oils often added to food during cooking. Check with your healthcare provider about the amount of fat grams you should be eating

dd to the challenges in developing combination products:

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

each day. Avoid fried foods, mayonnaise-based food, egg yolks, bacon and regular dairy products, choosing fat-free and low-fat dairy instead. Be sure to check

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

low- and fat-free dairy product labels to see how many carbohydrates they contain, and add those grams to your daily carbohydrate intake.

An important part o

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

a diet for managing diabetes is controlling portion size. Be sure you are eating the right amounts of the right foods to maintain a healthy diabetes diet.

I

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

f a diabetes diet isn’t totally controlling blood sugar levels, a doctor may prescribe diabetes medication. Medication does not cure diabetes, but helps manag

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

Professional from academic institutions, pharmaceutical industries, health care indust

insulin levels.

Diabetes Cure

For Type 1 diabetes, the closest thing to a cure most medical professionals point to is transplant of the pancreas, the organ

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

responsible for manufacturing insulin. Medical professionals and researchers are also developing an experimental procedure called pancreas islet cell transpla

.

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

nt. In this procedure, islet cells (which produce insulin) are transplanted from a donor pancreas into the patient’s pancreas.

Researchers are also working o

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

Companies that provide selfless information through particip

treatments to prevent and cure Type 2 diabetes. Clinical trials for several treatments are currently underway and can be researched at www.clinicaltrials.gov

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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