Tags |
|
|
Links |
|
|
Advice Pool - The Best Weight Loss Surgery Choice For Very High BMI Patients
There are a large number of choices available today when it comes to weight loss surgery, from the classical Roux-en-Y gastric byp
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
ass to laparoscopic or robotic adjustable gastric banding, but which is the best choice for patients with a particularly high BMI?
; 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
First we need to define what we mean by a particularly high BMI. It is generally accepted that obesity starts at a BMI of 30 and
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ecomes morbid obesity at 40. This is the point at which most doctors will consider a surgical solution to the problem. With a BMI
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
in the 40s patients are generally suitable for all forms of weight loss surgery (unless excluded by such things as co-existing med
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
cal condition) however, as BMI passes 50, the risks of gastric bypass surgery rise steeply and choices become limited. Against thi
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
background we would define a particularly high BMI as being 50 or above.
Despite the increased risks, some patients are nonethel
Despite the increased risks, some patients are nonethel
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
ess considered suitable and do opt for gastric bypass surgery while others take the safer route of gastric banding, but which is b
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
tter?
In a recent study involving 106 patients (all of whom had a BMI in excess of 50) 60 patients underwent gastric banding whil
In a recent study involving 106 patients (all of whom had a BMI in excess of 50) 60 patients underwent gastric banding whil
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
the remaining 46 opted for gastric bypass surgery. More than three quarters of the gastric banding patients suffered complication
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
, which included dehydration and vomiting, while less than one third of the gastric bypass patients suffered complications. In add
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
ition, the gastric banding patients experienced only about one third of the weight loss recorded for the gastric bypass patients.
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
Perhaps most surprisingly, more than three quarters of the gastric bypass patients were satisfied with their result and none regre
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
ted their choice. By contrast, less than half of the gastric banding patients were happy with the results and ten percent actually
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
expressed dissatisfaction or regretted their decision.
On the surface therefore it would appear that gastric bypass surgery is c
On the surface therefore it would appear that gastric bypass surgery is c
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
early the preferred choice. However, for many patients with a high BMI this is simply not an option as the risks are simply too hi
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
h, so what is the answer in these cases?
Without doubt the preferred option is a combination of restrictive surgery, such as gast
Without doubt the preferred option is a combination of restrictive surgery, such as gast
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ric banding, in the first instance to reduce weight to less than a BMI of 50 and then to follow this up with a second form of abso
.
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
ption surgery, such as the gastric bypass. In many cases however, rather than gastric banding, the preferred choice is to use a ve
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
tical gastrectomy (sometimes referred to as a vertical sleeve gastrectomy) as the first element in this two-stage surgical process
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.advicepool.org.ua/article/261279/advicepool-The-Best-Weight-Loss-Surgery-Choice-For-Very-High-BMI-Patients.html">The Best Weight Loss Surgery Choice For Very High BMI Patients</a>
BB link (for phorums):
[url=http://www.advicepool.org.ua/article/261279/advicepool-The-Best-Weight-Loss-Surgery-Choice-For-Very-High-BMI-Patients.html]The Best Weight Loss Surgery Choice For Very High BMI Patients[/url]
Related Articles:
Creating Job Opportunities At Work
Arranging A Free Debt Consolidation Quote
Bookmark it:
|