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Although the number of gastric bypass operations being carried out each year is growing as obesity rates continue to rise in m

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

any Western countries, weight loss surgery is still not considered by many to be a suitable solution for obesity in teenagers.

; 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 may however be changing and, while numbers still remain small, the number of teenage weight loss surgeries tripled betwe

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

en 2000 and 2003.

At present there are two issues as far as many surgeons are concerned when it comes to teenage obesity surg

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

ery. The first is whether or not the procedure is safe in adolescents and the second is how adolescent patients will fare in t

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

Combination pro

he longer term.

As far as the longer term effects of surgery are concerned this is a question that will only be answered in t

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

ime and once a large enough group of adolescents have been through surgery and meaningful statistics are to hand. In 2003, for

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

example, more than 105,000 bariatric operations were performed but, of these, less than 800 were performed on adolescents. Ev

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

en though some consider that this is a meaningful sample size on which to draw conclusions about the longer term effects of su

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

rgery, we will nonetheless still have to wait several years before any conclusions can be drawn.

In terms of surgical success

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

adolescents have proved to be excellent candidates for surgery, requiring less time in hospital, recovering faster than adults

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

Following aspects would a

and experiencing fewer surgical and post-operative complications. This is perhaps not too surprising when you consider that m

dd to the challenges in developing combination products:

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

ost adolescents enter surgery without the other major medical problems which are often seen in adults. Most importantly the de

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

ath rate from gastric bypass surgery in teenagers is very much lower than that seen in adults.

In addition to the two concern

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

s related directly to surgery itself there is also the wider question of whether or not we should be following this route at a

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

ll with teenagers. Weight loss surgery requires patients to make considerable changes to their lifestyle and there are psychol

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

Professional from academic institutions, pharmaceutical industries, health care indust

ogical issues to be faced both before and particularly after surgery. It is one thing for adults to tackle these issues, but m

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

any people question whether this a burden we should be placing on adolescents.

At this point there seems to be little doubt 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

hat gastric bypass surgery is an effective solution to the problem of obesity in teenagers but time will be needed to assess t

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

Companies that provide selfless information through particip

he longer term effects of surgery and to allow for further studies to be carried out into the psychological aspects of surgery

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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