E-Articles - Health and Fitness

First of all let’s look at what ‘enough’ is. Everyone has heard of the Recommended Daily Allowance or RDA. You find these listed as percent RDA on the back of all foods that you buy. What doe

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

s that mean? The RDA was developed in the 1920’s as a minimum requirement to avoid malnutrition. It was later improved in the 1950’s to include the amounts of vitamins and minerals needed for

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

Examples of combination products may in

‘normal growth’. Today’s scientific studies show that this is very different than the amounts that are probably needed to reduce the risk of chronic illnesses. The amounts of many vitamins (

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

not all) that are needed for most people to stay healthy in their adult years are likely to be much higher than the RDA. The fact is, we don’t really know what the exact optimal amounts of nu

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

trients are and they certainly vary for different people. But the bottom line is that the vast majority of us don’t get enough from our food. Studies have shown that most people who think the

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

Combination pro

are eating a healthy diet are not even meeting the RDA levels for all nutrients and most people are deficient in at least one if not several key vitamins.

So what does that mean? Think abou

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

t it like driving down the freeway with no seatbelts, no airbags, and old tires that could blow at any time. You might be fine. But if a tire blows and you get in a wreck what are your chance

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

s of coming out of it unscathed with no safety equipment. Proper nutrition works the same way in the body. It allows us to function optimally to fight off infections and common colds and to d

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

eal with the common physical and mental stressors that we face all the time. A minor deficiency in a key vitamin, mineral or other micronutrient shows up in the short term as lethargy, impati

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

ence and general fatigue and in the long term can increase your risk for cancer, heart disease, diabetes, depression and a large number of other chronic illnesses.

Where can you get good adv

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

ce? How about your physician, are they qualified to give you advise on optimal health and nutrition? Well, maybe. Ask your doctor if they have had any formal training in nutrition. It may sur

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

Following aspects would a

prise you to know that less that 10% of medical doctors get any formal training in nutrition in medical school. A doctor’s profession is really to help people that are sick get better. Doctor

dd to the challenges in developing combination products:

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

s are trained to diagnose and treat, and after medical school a large part of their training comes from pharmaceutical representatives that visit their office. They are not usually trained to

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

give advice on optimal healthy living. Most doctors are very reputable practitioners and adhere to high standards of patient care – but their customers are sick people trying to recover, not

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

people trying to achieve optimal health.

So what should you do? Your homework! Would you go and buy a car or a house without doing some homework first? Would you trust all of your money to

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

financial advisor without checking them out first? So why would you treat an investment into your health any differently? The fact is that the nutrition industry is regulated by the FDA as a

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

Professional from academic institutions, pharmaceutical industries, health care indust

food and to the same standards as frozen pizza. Many of the products on the market use cheap ingredients in sub-optimal amounts and in forms that are not easily utilized by the body. It is o

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

utside the scope of this article to give a detailed account of all of the products available but one source is a book called “The Comparative Guide to Nutritional Supplements” by Lyle McWilli

.

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

am. This provides a background into how nutritionals work in your body and also a detailed ranking of many of the products on the market. You can find it at amazon.com or many other bookselli

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

Companies that provide selfless information through particip

ng websites.

In summary, nutrition is key for life-long health and disease prevention. Do some homework and find high quality nutrition products that meet your needs.

Copyright 2006 Genesan

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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