E-Articles - Health and Fitness

We live in an age when more and more people are using surgery to improve both their looks and lifestyle through a "nose job

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

" here and a "nip and tuck" there. We are also seeing an increasing number of celebrities coming forward and openly discuss

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

Examples of combination products may in

ng their experience of weight loss surgery and how much easier it is to lose weight now with modern surgical techniques suc

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 laparoscopic adjustable gastric banding. It's perhaps no surprise therefore to find that people are increasingly lookin

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

at weight loss surgery in much they same way as they do cosmetic surgery.

Laparoscopic adjustable gastric banding may wel

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

Combination pro

l be a much simpler form of weight loss surgery these days but it is certainly far from being purely cosmetic and is not op

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

nly available to just anybody who decides that this is the way to go to solve their weight problem.

Weight loss surgery is

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

a serious business and is aimed at people with a Body Mass Index (BMI) of 40 or more. In other words, it's aimed at men tha

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

are at least 100 pounds overweight and women who are at least 60 pounds overweight. Or, to put it another way, it's aimed

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

at people whose weight problem is so severe that it is placing, or is likely to place, their lives at risk from the develop

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

ent of other associated health conditions.

As if this were not enough there are a whole range of other criteria that must

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

Following aspects would a

e satisfied before you are eligible for weight loss surgery, not the least of which is that you must have tried hard to loo

dd to the challenges in developing combination products:

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

e weight by just about every other means possible without success.

Assuming that you jump all of these hurdles and are per

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

mitted to have surgery, there is then the small matter of the risks involved (which are considerably greater than your aver

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

ge nose job) and the long and difficult post-operative period, which often brings a whole raft of medical and psychological

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

problems to contend with.

Laparoscopic adjustable gastric banding is an excellent form of weight loss surgery with many fe

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

Professional from academic institutions, pharmaceutical industries, health care indust

er risks and complications than some other forms of weight loss surgery and is certainly a godsend for many people sufferin

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

g from morbid obesity. It is not however, and should not be compared to or confused with, cosmetic surgery.

If you are con

.

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

emplating laparoscopic adjustable gastric banding for purely cosmetic reasons then think again. It may well be a good optio

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

Companies that provide selfless information through particip

for you, but you need to embark on this particular path for much wider and more important reasons than simply to look good

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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