Advice Pool - Health and Fitness

According to the National Center for Health Statistics:
• One third of all adult Americans are obese (20% above your ideal body weight).
• The average weight of

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

young American adults increased 10 pounds in seven years.
• 21% of American children are overweight (15% increase since 1980).
• Over 20% of youths 6-17 years ol

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

Examples of combination products may in

d are obese.
• 71% of Americans age 25 and over are overweight (up from 58% in 1983).

The failure to address these specific health problems has contributed

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

to the steep rise in health care costs. According to government studies, obesity-related conditions are costing over $100 billion a year and causing 300,000 premature dea

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

ths in America per year. The U.S. Surgeon General’s report on nutrition and health states that about 35 million Americans have serious health problems related to being ove

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

Combination pro

weight. Obesity dramatically increases the risk of developing heart disease (baby boomers are beginning to suffer heart attacks, driving up cardiovascular deaths for the f

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

irst time since 1980, according to the American Heart Association). Obesity increases the risks of diabetes, high blood pressure and digestive and pulmonary diseases.

Eve

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

ryone wants to lose weight but people are inundated with conflicting, often misleading, but above all, unstructured information about how to lose weight. There are answers

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

and they all have to do with understanding metabolic stress. It has everything to do with becoming healthy and reducing the total amount of stress on your system. Let’s l

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

ook at one kind of metabolic stress.

Blood sugar regulation is one of the most critical problems associated with metabolic stress. What does it really mean? Your body mak

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

s insulin to help you regulate the sugars you eat. Here is how it works:

Hypoglycemia. People with low blood sugar can be extremely sensitive to insulin. Sugar is quickly

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

Following aspects would a

pulled out of the blood and either stored as fat or made into energy. Unless these people can compensate for this sugar imbalance they will have extremely low blood and b

dd to the challenges in developing combination products:

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

rain sugar levels. There are literally no limits to the physical, mental and emotional hypoglycemic symptoms these people experience.

People are not sensitive to insulin.

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

They produce tremendous amounts of insulin in a desperate attempt to push the sugar out of the blood into the tissues, but to no avail. The chronically high levels of ins

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

ulin levels of these people set off a chain of reactions. One is Adult Onset Diabetes. Liver function goes way down, blood pressure goes way up, hormone systems are not ef

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

icient and the person begins to age prematurely because of this stress.

Now the body functions poorly. Stressfully. This metabolic stress causes overload on the entire sy

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

Professional from academic institutions, pharmaceutical industries, health care indust

stem. You have to change the imbalances.

What do you do? Start by cleaning up your diet. I mean CLEAN it up. Stop eating junk. You must realize that 75%-90% of your diet

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

has to be raw. Yes, out of the garden. There’s a whole other world out there. The majority of your groceries have to come from the produce section of the market. If you ca

.

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

n get your food at a local farmer’s market, even better. Eating for health has to become a priority. Eating for pleasure has to disappear.

Metabolic stress is just one of

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

Companies that provide selfless information through particip

the six major stresses that you have. It is a major one nonetheless. So let’s make it a priority this year because you have five more to go to clear out to become healthy

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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