E-Articles - Health and Fitness

Obesity” states U.S. National Institute of Health (NIH). Today, ninety-six million Americans are considered obese. But, what can be done to re

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

verse the trend?

Try a low glycemic diet that is rich in whole grains and low in refined sugars

Exercise regularly and for sustained per

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

Examples of combination products may in

iods of time

Get enough sleep (studies show that adult dieters who get less than eight hours of sleep per night lose less weight than

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

those who get eight hours or more)

Drink water - at least eight glasses per day

The trend is not absolute and can b

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

e altered dramatically. There are factors that contribute to obesity.

1. Genetics 2. Environment

3. Our Behaviors

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

Combination pro

blockquote>What are some of the negative impacts of obesity

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

Diabetes. A large majority of diabetics have acquired the disease directly because of their obesity. They are now chained to a l

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

fe of taking pills, or even worse, taking insulin shots. Diabetes leads to all sorts of other health complications, as well.

Heart at

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

tack. People who are obese are at a significantly higher risk of having a heart attack. This fact is proven over and over again. Sudden cardia

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

c arrest is a fairly common cause of death for someone who is obese.

Cancer. Obesity also increases the chance of acquiring a number

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

of cancers. Yes, it is true. Although this connection wasn't clear for years, it is crystal clear now.

Joint problems. Obesity also l

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

Following aspects would a

eads to joint problems. Excess weight puts significant stress on each joint, even with the simplest of activities. Many obesity sufferers have

dd to the challenges in developing combination products:

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

knee problems for this very reason.

Sleep apnea. Respiratory problems are quite common, as well. The most common is sleep apnea. Peo

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

ple who are diagnosed with this have a very difficult time breathing while they sleep. This makes them more tired during the day. A

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

ecent study published by the Center for Disease Control (CDC) states that the combined direct and indirect health care costs resulting from ob

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

ese and overweight Americans is estimated to be $117 billion per year. Statistics also demonstrate that death rates increase at least 200% for

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

Professional from academic institutions, pharmaceutical industries, health care indust

people who are 50 pounds or more overweight.The National Institute of Health (NIH) has stated that an increase of 20% beyond ‘ideal body weig

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

ht’ is the point at which excess weight becomes a health risk. There are many diseases which often follow obesity – such as high blood pressur

.

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

e, high cholesterol, diabetes, sleep apnea, respiratory problems, bone and joint problems, coronary artery disease, stroke, some cancers, and

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

Companies that provide selfless information through particip

many others. Each of these independently can have serious consequences to one’s health. The medical risks of diabetes are indeed profound.

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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