E-Articles - Health and Fitness

Obesity results when too much fat accumulates in the body. A person is normally considere

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

d obese when his or her weight is 20% over the normal body-weight for height and age and

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

Examples of combination products may in

he Body Mass Index (BMI) measures 30 or more. Now recognized as a serious medical problem

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

obesity affects about 30% of adults, and about 14% of children and adolescents in the Un

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

ted States.

Obesity may be caused by a number of social, cultural, behavioral, physiolog

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

Combination pro

cal, metabolic, and genetic factors that are beyond the person’s control. Symptoms of obe

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

ity usually show up in the form of breathing trouble, excess accumulation of fat, insulin

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

resistance, increase in size or number of fat cells, rise in blood pressure, high cholest

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

rol levels and back pain.

A variety of treatments exist for obesity that includes diet a

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

d behavior therapy to medicine and surgery. The treatments usually depend on the levels o

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

BMI, while others may be an individual choice. While diet therapy involves a prescribed

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

Following aspects would a

iet and exercise plan, behavior therapy teaches new behaviors that promote weight loss. I

dd to the challenges in developing combination products:

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

a person’s condition demands so, a doctor may recommend a combination of both. For a per

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

on having a BMI of 40 or a BMI of 35 to 39.9 accompanied by serious medical problems, doc

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

ors usually recommend gastrointestinal surgery.

The old adage, ‘prevention is better tha

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

cure’ holds true in the case of obesity also. While many genetic factors that may cause

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

Professional from academic institutions, pharmaceutical industries, health care indust

besity are beyond a person’s control, the other factors can be prevented through educatio

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

, knowledge, a good diet, and exercise. If you teach your children healthy eating and exe

.

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

cise and make them aware of the dangers associated with obesity, it is highly likely that

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

Companies that provide selfless information through particip

they will carry this knowledge and these behaviors into their adulthood and avoid obesity

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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E-Articles - An Introduction To Obesity

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