E-Articles - Health and Fitness

The risks of obesity include heart disease, diabetes, stroke, low back pain, sleep apnea

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

, depression, high cholesterol, joint problems, among others. A recent study published b

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

Examples of combination products may in

the Center for Disease Control (CDC) states that the combined direct and indirect healt

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

care costs resulting from obese and overweight Americans is estimated to be $117 billio

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

per year. Also, statistics demonstrate that death rates increase at least 200% for peop

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

Combination pro

e who are 50 pounds or more overweight.

Obesity is a disease which is defined as the st

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

ate of being a certain level of overweight. There is a statistical methodology that doct

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

rs use to quantify this level, which is known as the Body Mass Index (BMI) chart. This s

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

mple tool helps doctors create a baseline for their patients, and serves as a method to

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

onitor change.The National Institute of Health (NIH) has stated that an increase of 20%

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

eyond ‘ideal body weight’ is the point at which excess weight becomes a health risk. Eac

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

Following aspects would a

h of these independently can have serious consequences to one’s health. The medical risk

dd to the challenges in developing combination products:

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

of diabetes are indeed profound. Unless Americans make the effort to become educated, a

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

d receive guidance to move toward their weight loss goals, the health of America will on

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

y get worse. Unless change is believed to be critical, the anticipated health care costs

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

will only be increase. Please become informed, in one way or another, so we as a country

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

Professional from academic institutions, pharmaceutical industries, health care indust

can start becoming healthier.

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

get="_blank">Dr. Janet Bruno is at the forefront of initiating a major campaign to e

.

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

ucate the American public on the real facts of obesity. She believes that the public mus

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

Companies that provide selfless information through particip

first recognize obesity as the disease that it really is before any action can be taken

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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