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So What is gastric bypass surgery?

Gastric bypass surgery is a procedure aimed at helpin

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

g people lose weight by making the stomach smaller and bypassing a part of the small intestine.

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

Examples of combination products may in

This results in eating less (because you feel full more quickly) and absorbing fewer calories (

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

because the food does not spend as long in the intestine).

Who should consider?

Gastric

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

bypass is a serious surgical procedure designed to help a serious problem. Generally, gastric

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

Combination pro

bypass is not considered unless the patient is more than a hundred pounds overweight, has a body

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

mass index of greater than 40, or has serious health conditions related to obesity.

What ar

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

e the benefits ?

Gastric bypass usually results in rapid weight loss, with people losing up

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

to a third of their body weight within one to five years.

This can help control other weight-r

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

elated conditions such as diabetes, high blood pressure and cholesterol, etc. Some gastric bypa

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

ss patients report going from taking a dozen medications or more to taking only one or two.

Peo

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

Following aspects would a

ple have also reported benefiting socially and emotionally from gastric bypass surgery, with the

dd to the challenges in developing combination products:

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

weight loss allowing them to participate in more activities they enjoy.

What are the risks

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

?

Gastric bypass is major surgery, and anyone who undergoes it runs all the risks normally

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

associated with surgery. These risks may include infection, bleeding, and even death. In addit

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

ion, people who have undergone gastric bypass may suffer from nutritional deficiencies.

Even af

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

Professional from academic institutions, pharmaceutical industries, health care indust

ter enduring the trauma of gastric bypass, not everyone is able to keep the weight off. If the

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

patient continues to overeat, the stomach will, in time, re-expand.

Getting gastric bypass surg

.

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

ery is not a magic bullet for obesity. Rather, it is the beginning of a new, nutrition-consciou

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

Companies that provide selfless information through particip

s lifestyle that the patient must carefully maintain in order to lose the weight and keep it off

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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