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The world today is facing an alarming health problem with obesity. Over

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

weight among people is result of bad dietary habits, lack of exercise a

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

Examples of combination products may in

d a sedentary life-style. The main cause though is poor diet. Keeping

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

low fat, high fibre diet is one way of countering weight problems. Oa

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

ts is an excellent organic food that helps maintain a healthy weight an

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

Combination pro

is essential in a long-term health diet. More and more people are bec

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

ming health conscious and turning to meatless, low cholesterol foods, 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

hich has led to the recognition of oats a natural food in the fight aga

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

nst obesity.

By consuming Oats and its ingredient Beta-glucan a person

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

can maintain a healthy weight.

• B-glucan present in Oats delays the s

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

omach from emptying contributing to a longer feeling of being full.

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

Following aspects would a

r>• The high fibre in Oats help you feel fuller longer but without prov

dd to the challenges in developing combination products:

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

ding any calories.
• The presence of B-glucan in the small intesti

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

e slows down the nutrient absorption process leading to a longer feelin

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

g of satiety.
• Oats assists weight maintenance and reduction by 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

creasing the amount of fat discharged in the faeces.
• When consum

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

Professional from academic institutions, pharmaceutical industries, health care indust

d with other organic foods the effects of Oats B-glucan are even strong

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

er.

Velle oats website is in Russian language so people who know Russi

.

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

n can understand the goodness of oats and its impact on health.

I will

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

Companies that provide selfless information through particip

recommend all the readers to visit the website to read further articles

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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