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Approved as recently as 2001 by the FDA, laparoscopic adjustable gastric band surgery is fast becoming accepted as the safest and least invasive form of we

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

ight loss surgery.

Lap band surgery is a form of purely restrictive weight loss surgery and uses a small inflatable band around the upper portion of the p

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

Examples of combination products may in

atient's stomach to restrict the quantity of food that the patient can consume and also to slow the emptying of food from the stomach so that the patient h

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

as a constant feeling of being full. Like many surgeries today, lap band surgery is often performed laparoscopically and operations typically take about on

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

e hour, with patients being required to remain in hospital for no more than one night following surgery.

A normal stomach will have a capacity in excess o

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

Combination pro

f 1000 ccs but laparoscopic adjustable gastric band surgery typically reduces this to as little as 15 to 30 ccs. This very much reduced stomach size limits

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

the intake of foods severely and forces the body to begin burning off its fat reserves, thus creating weight loss.

One beauty of this particular form of

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

weight loss surgery is that the surgeon is able to adjust the restriction on the stomach post-operatively through a port which is embedded in the wall of t

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

he abdomen just under the skin. This allows the surgeon to monitor the patient's progress and to either increase or restrict further the amount of food tha

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

t an individual can consume. This feature of lap band surgery not only leads to a safer recovery, but also results in a healthier long term weight loss.

P

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

atients must of course adhere to a strict diet following surgery and for some 18 months will be restricted to consuming less than 800 calories per day. Bet

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

Following aspects would a

ween 18 and 36 months patients will normally increase their intake gradually until they are consuming about 1200 calories each day. Patients will also need

dd to the challenges in developing combination products:

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

to learn to drink fluids in small quantities throughout the day, avoiding fluids with meals, and will need to take nutritional supplements for the remaind

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

er of their lives.

Most patients undergoing laparoscopic adjustable gastric band surgery will experience a weight loss of approximately 60% of their exces

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

s weight, which is slightly less than would typically be seen in other forms of gastric bypass surgery.

Although there are many advantages to lap band sur

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

gery it is not without its problems, including such things as a malfunction or slippage of the band, problems with the adjustment port, erosion of the band

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

Professional from academic institutions, pharmaceutical industries, health care indust

into the wall of the stomach and infection. Perhaps its biggest problem for many patients though is the fact that weight loss tends to be fairly slow and,

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

of all the procedures performed today, lap band surgery requires the greatest effort on the part of the patient in order to lose weight and to maintain th

.

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

at weight loss.

Although lap band surgery is certainly a very popular option, it is not for everybody and patients undergoing laparoscopic adjustable gast

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

Companies that provide selfless information through particip

ric band surgery need to be disciplined when it comes to following a strict diet and, ideally, should be prepared to undergo and enjoy an exercise program.

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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