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E-Articles - Gastric Bypass - The Advantages of Laparoscopic Surgery
Gastric bypass is the most frequently undertaken operation for weight loss in the United States with about 140,000 surgeries being carried out every year. With
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
a history dating back over 50 years, hundreds of surgeons have grown up with gastric bypass surgery and have developed a very good understanding of its benefi
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ts and risks.
Gastric bypass surgery is the final option when other types of dieting and weight loss have been unsuccessful and where you are considerably ove
Gastric bypass surgery is the final option when other types of dieting and weight loss have been unsuccessful and where you are considerably ove
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
rweight. This normally means that you have a body mass index (BMI) greater than 40, or greater than 35 with an accompanying condition which increases the risk
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
of disability or premature death. Such conditions would include heart disease, obstructive sleep apnea, hypertension and liver disease amongst others. In its s
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
mplest form, this equates to being some 100 pounds more than your ideal weight.
The principle behind the gastric bypass procedure is quite simply to lower the
The principle behind the gastric bypass procedure is quite simply to lower the
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
size of the stomach and to bypass the larger part of the stomach, as well as part of the intestine, constraining your ability to eat excessively and also redu
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
cing the body's absorption of the food that you do eat.
Despite the fact that open gastric bypass procedures are still commonly undertaken a growing number of
Despite the fact that open gastric bypass procedures are still commonly undertaken a growing number of
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
surgeons are moving to the laparoscopic approach and, though this takes considerable training and expertise on the part of the surgeon, there are a variety of
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
advantages to this approach. Here are just some:
1. Because patients are up and about very quickly following surgery there is a lower risk of pneumonia, bloo
1. Because patients are up and about very quickly following surgery there is a lower risk of pneumonia, bloo
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
clots, bed sores and other complications generally associated with immobility.
2. This type of surgery allows for greater precision because the procedure is
2. This type of surgery allows for greater precision because the procedure is
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
done under magnification and surgeons can observe details not visible during traditional open surgery.
3. As the laprascopic procedure is quicker than open su
3. As the laprascopic procedure is quicker than open su
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
rgery the patient spends less time in the operating theatre and needs less anesthesia, bringing about fewer anesthesia-related complications.
4. This type of
4. This type of
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
surgery permits you to go back to work in a relatively short timescale, normally as little as one week although it is recommended that patients do not go back
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
to work for around two weeks to be on the safe side.
5. Patients experience very much less post-operative pain and what little pain there is requires only mil
5. Patients experience very much less post-operative pain and what little pain there is requires only mil
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
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
painkillers like codeine and paracetamol.
6. As commonly only 5 short incisions are made during this form of procedure the time that it takes to heal followi
6. As commonly only 5 short incisions are made during this form of procedure the time that it takes to heal followi
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ng surgery is considerably reduced, as is the possibility of infection and of the complications of a subsequent hernia.
Gastric bypass produces a significant
Gastric bypass produces a significant
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
improvement in the quality of life for patients and also has the further benefit of improving, or in many cases of curing, headache, venous status disease, art
.
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
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
hritis, heartburn, diabetes and other disorders.
The fact that the procedure itself can now be done so much more easily and leave patients quite pain free and
The fact that the procedure itself can now be done so much more easily and leave patients quite pain free and
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
have them on their feet rapidly means that a growing number of people are likely to opt for gastric bypass surgery and enjoy a happier and healthier lifestyle
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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