E-Articles - Health and Fitness

Carbohydrates come from a wide array of foods – bread, pasta, fruits, doughnuts, ice creams and pie. Carbohydrates refer to a group of molecules that is made up of small sugar units composed of carbon, hydrogen

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

and oxygen. They are needed by the body and therefore included in our diet as a major source of energy. Some carbohydrates are simple and are made up of small units of sugars while others are made up of several

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

Examples of combination products may in

nits of sugar arranged in chains or branches. A healthy diet cannot go without these molecules.

Carbohydrates give body cells the source of energy to support all their activities. This is the reason why when th

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

body's sugar level is so low, the person experiences a feeling of weakness and lack of energy. This can be observed with diabetics when their blood sugar level go below the normal level. They also provide us wi

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

h fiber, one of nature's brooms to purge the body of toxins and waste materials. However, one major concern in carbohydrates is that when they are taken in excess, some of them get converted to stored forms such

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

Combination pro

as fat and stored in certain tissues of the body, usually under the skin. This accounts for pot bellies and love handles and other unsightly bulges on certain areas of the body.

If you are very serious about tr

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

mming your waist and dropping pounds, one diet program that you might want to try is one that is low on carbohydrates. Low carbohydrate diet programs are quite popular these days in the form of the South Beach D

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

iet, Atkins diet and Zone Diet. Basically these diet programs promote one thing: restriction of consumption of carbohydrates.

This is on the basis of researches that show the connection between high carbohydrat

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

consumption affecting blood insulin levels to cause metabolic syndromes and obesity. Low carbohydrate diet programs therefore limit or replace foods rich in carbohydrates with those that contain more proteins,

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

ats and fiber. In a low carb diet, there is less bread, pasta, potatoes, rice, and cereals. They usually eat more vegetables, meat, fish, cheese, eggs, and nuts. When one opts to go on a low carbohydrate diet, o

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

e has to replace carbohydrates with fats and proteins. Carbos in fact make up less than 10 percent, and in some cases, less than 5 percent of the daily calorie intake.

Low carbohydrate diet for one, go for food

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

Following aspects would a

that are low in sugar. Processed sugar should be greatly reduced, if not totally eliminated from the diet. Low carbohydrate diet food is made up mostly of vegetables, more specifically non- starchy ones. A serv

dd to the challenges in developing combination products:

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

ng of at least 3- 5 cups per day is highly recommended for this type of diet.

Protein is also an essential parts of a low carbohydrate diet so foods rich in it are highly recommended. One low carbohydrate but p

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

otein rich food is soy - based food like tofu and certain meat substitutes.

Fruits that are low in sugar are also tops in the list of low carbohydrate diet foods. A serving of 1-3 per day is enough. As much as

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

possible, it is recommended to eat the fruit itself and to not simply drink the juice to also meet the body's need for fiber and vitamins. Fruit juices also tend to increase the body's blood sugar so it is best

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

o eat the fruit instead.

Nuts and seeds as well as legumes are also some low carbohydrate foods that can be included in the diet. Nuts and seeds are even used by some to replace starchier foods. They are also e

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

Professional from academic institutions, pharmaceutical industries, health care indust

cellent source of healthy oils and fiber. Legumes like beans and peas may contain carbohydrates but they are those that can easily be broken down and digested so there is no need to get rid of them entirely. The

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

same thing is also true for whole grains like brown rice and whole grain pasta.

As for oils and fats, a low carbohydrate diet opts for oils coming from olives as well as from fish. Fish oil is rich in omega-3 w

.

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

ich is good for the heart. So eating more fish to get the full benefits of omega 3 and protein is highly recommended too.

Going on a low carb diet does not necessarily mean sacrificing a lot of food and getting

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

Companies that provide selfless information through particip

deprived. It simply means shifting to foods that are less in carbohydrates and more on proteins and even fats. The foods included in the low carb diet are even more flavorful since they contain proteins and fats

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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