E-Articles - Health and Fitness

Low carbohydrate eating has gained a lot of popularity during recent years, though it has been around for decades. As much as the 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

pporters of a low carb (high protein) diet believe in it, opponents to this eating plan are equally vocal. Many of the objections st

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

Examples of combination products may in

m from a belief that low carbohydrate means a diet high in fat. In truth, this is not the case.

One can choose low carbohydrate and

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

high fat, but the wise, health-conscious low carbohydrate diner has the same choices to make as any other healthy eater. That is, to

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

choose better foods and better cooking methods.

For the person wanting to eat low carbohydrate, this means choosing good oils, stea

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

Combination pro

ing rather than frying, buying lean cuts of meat and fat-reduced cheese, such as Edam. These exact same questions face anyone trying

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

to maintain a healthy eating lifestyle.

Full fat cream cheese, sour cream, cream, and butter are the better than their fat-reduced

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

ounterparts for the purposes of a low carbohydrate diet. This is in part due to low fat versions tending to contain a much higher ca

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

bohydrate content. However, the main reason is because the body burns fat. Excess sugars, which are ingested and cannot be used by t

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

e body, are converted to fat – that is, they create fat. Without an intake of refined sugars, the body is then forced to burn its ow

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

fat stores for energy. This is why many people turn to a low carbohydrate diet in order to shed their excess weight.

This is where

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

Following aspects would a

a lot of the myth begins that low carbohydrate means high fat. Again, the choice lies in how much of these foods you wish to put int

dd to the challenges in developing combination products:

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

your everyday diet. A ‘normal’ eater may slather cream cheese on bagels, butter on bread, and sour cream on potatoes. Removing the

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

arbohydrate-rich starchy foods from this equation does not increase the fat intake. When taken into context, low carbohydrate is onl

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

high fat if you choose to eat that way.

Low carbohydrate is an eating lifestyle, which eliminates simple sugars and drastically re

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

uces complex sugars, such as those found in grains, rice, and bread. This eating lifestyle could almost be termed as ‘low processed

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

Professional from academic institutions, pharmaceutical industries, health care indust

oods’. That is, foods which are as natural as possible. Vegetables, meats, and dairy are the mainstays of this diet, topped up with

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

ise carbohydrate choices such as fruit and potato (rather than bread or pasta).

Low carbohydrate eating may seem at face value as t

.

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

ough it is high in fat. In fact, given the choices between highly processed, sugar-laden modern foods and the natural form of animal

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

Companies that provide selfless information through particip

and vegetable products, one should not have too much difficulty in seeing where improvements, for the sake of one’s health, are made

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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