E-Articles - Health and Fitness

Because weight loss surgery (WLS) is a life changing action it is imp

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

ortant to understand why you are heading down this path. WLS is not

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

Examples of combination products may in

n end all to your weight problems. In fact patients have been unsucc

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

ssful in reaching target weight loss or returned to their former weig

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

t after WLS.

It is important to understand that this procedure is ju

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

Combination pro

t a tool to help you regain control over your life and your health.

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

You will still need to change your eating habits for life. You will

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

till need to change your exercise habits for life. WLS will not by i

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

self change your self esteem, popularity, physical attractiveness, or

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

other issues you may currently have as a result of your obesity.

Fre

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

uently your weight is only a symptom of other issues you will need to

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

Following aspects would a

deal with in these areas.

WLS can help improve your overall health.

dd to the challenges in developing combination products:

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

Long term weight loss of 10% or less can result in a decrease in blo

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

d pressure, improve cholesterol levels, and help control blood sugar.

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

In addition you may see improvements in sleep apnea, a lessening of

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

ain in weight bearing joints like knees and ankles, and a general inc

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

Professional from academic institutions, pharmaceutical industries, health care indust

rease in your ability to breath.

Additional weight loss may also res

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

lt in a decrease in heartburn and gastrointestinal discomfort. Many

.

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

LS patients have also reported decreased reliance, and sometimes tota

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

Companies that provide selfless information through particip

elimination of, the need for diabetes and blood pressure medications

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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