E-Articles - Health and Fitness

For morbidly obese individuals who have found it impossible to lose weight by other means, laparoscopic weight loss surgery can b

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

e a life saving procedure, but it carries with it substantial lifelong medical implications.

Laparoscopic weight loss surgery pe

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

Examples of combination products may in

rmanently alters the digestive system and, in addition to the surgical risks that the procedure itself carries, there are a varie

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

ty of medical implications for those undergoing weight loss surgery including long-term digestive problems, vomiting, bowel irreg

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

ularities and vitamin deficiencies to mention just a few.

The risks and complications of surgery will of course to some degree d

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

Combination pro

epend upon the type of surgery selected. Surgical recovery is often easiest after laparoscopic weight loss surgery as a result of

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 need for only a small number of tiny access incisions, rather than the need for a single large incision in the lower abdomen

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

, as is the case with traditional open surgery. Post-operative recovery at home is also typically faster, leading to fewer long-t

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

erm medical problems which can arise from an extended recovery period.

For those suffering from morbid obesity, laparoscopic wei

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

ght loss surgery offers the chance of a new life with the opportunity to not only enjoy the benefits that come from a dramatic re

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

uction in weight, but also to cure, or improve, a range of other health problems that are caused or aggravated by obesity.

But t

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

Following aspects would a

hese improvements in both health and quality of life come at a price and, as with anything else in life, patients must decided fo

dd to the challenges in developing combination products:

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

r themselves whether or not this is a price they wish to pay. For example, patients need to relearn to art of eating and will nev

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

er again enjoy eating in the manner in which they do now. They will also often need to take such things as vitamin and mineral su

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

pplements for the remainder of their life.

They may also develop a lifelong intolerance to certain types of food (especially fat

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

ty foods) and, certainly in the months immediately following surgery, may experience flatulence, nausea, vomiting and problems wi

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

Professional from academic institutions, pharmaceutical industries, health care indust

th dehydration. Hernias and gallstones are also not uncommon following laparoscopic weight loss surgery.

Many individuals who ar

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

e suffering from morbid obesity are not only facing a barrage of health problems but often find that their quality of life is int

.

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

olerably reduced and that laparoscopic weight loss surgery offers a solution. The only question is whether or not the price that

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

Companies that provide selfless information through particip

has to be paid for this solution is acceptable and, for an increasing number of people, the answer to that question is that it is

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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