E-Articles - Health and Fitness

The general accept is that obesity is genetic. But the combinatio

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

n of obesity and its stability almost always equates increased qu

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

Examples of combination products may in

stions related to ways to maintain a normal weight.

St

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

ble obesity:
When one is stable at a "set point" more then 2

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

lbs (more or less) above what is considered ideal for ones heigh

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

Combination pro

and weight and finds it hard to lose (or gain, but who complains

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

about that) away from that "set point". It is my opinion (and eve

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

ybody's got one :) that many of these people would be better off

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

here they are at then going to war with their bodies and screwing

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

up their metabolisms.

If a stable obese person wants

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

o lose weight he should attack it primarily from the exercise end

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

Following aspects would a

of the spectrum. Even if that doesn't work he will still be more

dd to the challenges in developing combination products:

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

it and healthy in the long run.

Unstable obesity:

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

When one doesn't seem to have a "set point" and slowly gains wei

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

ht over time. This is a genuine metabolic disorder and it may be

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

aused by disease, genetics, or simply by a long history of eating

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

Professional from academic institutions, pharmaceutical industries, health care indust

when one is not really hungry (comfort eating) and/or a sedentary

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

lifestyle.

Whatever the cause, it should be treated l

.

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

ke a disease and not a "character flaw". The weight needs to boug

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

Companies that provide selfless information through particip

t down before he gets so fat that it interferes with his mobility

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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Definitely something to think about. If trucks stop shelves empty in 5.5 days, people starving the next week, anarchy in the streets within three weeks. Yes even in your nice suburban town. Think about it.

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E-Articles - There Are Two Kinds of Obesity?

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