E-Articles - Health and Fitness

So you’ve reached the end of the line, and you have two possible endings – one is complete recovery, and the other the opposite.

Obesity surgery is the last rec

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

ommended treatment for the most severe cases of obesity. Yet the last treatment is still meant to be a ‘treatment’, a remedy for you to gain back the health you

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

Examples of combination products may in

nce lost. To assure you of a safe obesity surgery pay attention to these important life-saving measures and information:

First to keep in mind is that obesity s

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

urgery is meant for serious obesity cases, meaning obesity problems that have been impossible to eliminate after trying all possible weight-control and weight-lo

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

s methods. Obesity surgery or specifically, Bariatric surgery (also Gastrointestinal surgery), is reserved only for cases of severe obesity that have been resist

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

Combination pro

nt to all other obesity treatments.

Second to consider is that obesity (Bariatric) surgery offers several types to choose from. Nonetheless, the risks for eithe

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

r of the obesity surgery types are similar, and the prospective results and outcome are also comparable.

The first obesity surgery method is called the Restrict

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

ve Weight Loss Surgery which includes ‘stomach-stapling’ aiming to restrict the obese patient’s amount of food to be consumed at a single sitting. In the process

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

the doctors cut and create a small pouch at the top of the stomach capable of holding about 1-ounce of food. The small opening at the bottom of the pouch holds

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

food and causes a feeling of fullness. After the surgery, the patient can eat no more than ?-cup to 1-cup of well-grinded insipid food at one time without being

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

pset. The ‘lap-banding’ variation of the surgery doesn’t need to cut into the stomach or intestine of the patient. Rather, a silicone-band is wrapped around the

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

Following aspects would a

pper stomach to create a pouch, making patient recovery-period shorter while also reducing the risks for surgery complications.

The second type of Bariatric met

dd to the challenges in developing combination products:

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

hod is the more common Mal-absorptive Surgery which includes the ‘gastric bypass’ procedure. The purpose of this surgery is to prevent the effective absorption o

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

nutrients from eaten food by ‘bypassing’ most digestion in the food’s path. The mal-absorption results in significant weight-loss and reduced appetite; yet it a

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

so results in chronic diarrhea, stomach ulcers, flatulence and foul-smelling stool, a dumping syndrome characterized by fainting, nausea, sweating and diarrhea a

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

fter eating, and the risk of nutritional deficiencies.

Patients opting for any of the Bariatric surgeries would first have to undergo a scrutinized medical eval

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

Professional from academic institutions, pharmaceutical industries, health care indust

ation to determine his suitability for the surgery. Candidates include those who are at least 80-100-pounds overweight and have been unsuccessful with traditiona

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

weight-loss methods. Patients having physical problems but require weight-loss may also be candidates for an obesity surgery.

Once you’re qualified for the sur

.

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

gery, you would have to realize several other important things such as the required lifelong medical supervision after the surgery, the continuing need for lifes

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

Companies that provide selfless information through particip

yle and dietary changes, and the seriousness of the surgery risks requiring full-provision of physical and emotional support before, during and after the surgery

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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