E-Articles - Health and Fitness

Obesity is the bane of the modern ‘fast food’ world. Obesity surgery is an answer to all the ‘weighty issues’ faced by an individual. In t

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

une with the times, it is a quick answer, to a problem that otherwise could take years to be solved.

As the name suggests, obesity surger

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

Examples of combination products may in

, is a surgical procedure that enables a person to lose weight. It is specifically for those people, who have just about tried everything,

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

to lose weight or tried hard to maintain their weight loss but failed in all their attempts. Though obesity is relatively harmless, as co

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

pared to other medical conditions, it does lead to health problems in the long run and decreases a person’s life expectancy. For these rea

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

Combination pro

sons, weight reduction assumes paramount importance.

A person should ideally go for obesity surgery, if he/she suffers from morbid obesit

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

. Morbid obesity is a condition wherein individuals have a body weight that is 50 to 100% above what is measured by the Body Mass Index (B

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

MI). The BMI is calculated taking into consideration a persons weight in relation to his/her height. In medical parlance, a BMI between 30

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

40 is considered obese and that lying over 40 is considered morbidly obese.

At times obesity manifests itself in cycles. A person can dra

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

stically reduce weight and in a little time might just gain weight drastically. This is why new, improved and innovative weight reduction

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

easures are being introduced and among these is, obesity surgery. Obesity surgery is not as drastic a measure as many people believe it to

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

Following aspects would a

be. An invasive medical procedure has some amount of associated risks, as is the case with obesity surgery. However, there are numerous b

dd to the challenges in developing combination products:

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

riatric surgeons, who are experts in this type of surgery. Coupled with state-of-the-art hospitals and medical clinics, the complications

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

are minimized to a great extent.

Many regard obesity surgery as a quick fix solution, but nothing can be farther from the truth. It is a

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

omprehensive procedure that also includes, among other things, superior support and services of other medical professionals like dietician

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

s and psychologists. The treatment plan is drawn out over a long period of time. Obesity surgical procedure involves the placement of the

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

Professional from academic institutions, pharmaceutical industries, health care indust

astric band in the upper portion of the stomach. This limits an individual’s intake of food. This is accomplished by using what is known a

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

s laproscopic surgery also known as keyhole surgery. This gastric band or the lap band is adjustable in nature and if need be, can be remo

.

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

ed altogether.

The post-operative care includes an overnight stay in the hospital, following the operation. It also includes regular cons

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

Companies that provide selfless information through particip

ultations with health care professionals, who will counsel you regarding the subsequent life style changes that a person needs to adapt to

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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