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How Can Fat Be Essential?

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

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

Examples of combination products may in

t-size: 10.0pt"> Did you know that some fats are essential to the body? Yes, there are some fats that our body cannot produce which means that we must get them from our food.

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

e="mso-spacerun: yes"> Perhaps you’ve heard of omega-3 fatty acids and omega-6 fatty acids. These are both considered essential and must be supplied by the foods we eat.

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

class=MsoNormal style="MARGIN: 0in 0in 0pt"> What do they do? Well, the omega-3 fatty acid, for example is used for the production of healthy cell membranes and for the production of a class of hormones called prostaglandins.

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

Combination pro

PAN style="mso-spacerun: yes"> You know how aspirin and acetominophen are anti-inflammatories? So are the prostaglandins that our bodies produce from omega-3 fatty acids.

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

class=MsoNormal style="MARGIN: 0in 0in 0pt"> Now, we need the omega-3’s and the omega-6’s to be in the proper combination to be most effective to us. Empirical evidence shows that the proper ratio is about 4:1 between omega-6

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

and omega-3 fatty acids. What do you suppose our average diet gives us? About a 20:1 and up to a 40:1 ratio; not even close to the optimal ratio.

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

Why is the balance so out of whack? Well, our normal diets are rich in omega-6 fatty acids. We get them from meats, dairy products, an

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

d processed foods. We eat a lot of those foods on average. We get omega-3 fatty acids from certain vegetable oils such as flaxseed, canola, and soybean. And we get omega-3 fatty acids from cold-water fish such as mackerel, sardines, salmon, and tuna.

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

Eat more fish! You’ve heard t

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

Following aspects would a

hat said before, and now you know why.

Especially th

dd to the challenges in developing combination products:

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

e salmon. It is especially rich in the beneficial omega-3 fatty acids. Salmon , or any of the other omega-3 rich fish (but what tastes better than good salmon?) should be consumed at least once a week.

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

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In order to get the omega-6 vs. omega-3 ratio in order, decrease your consumption of the saturated fat from meats and dairy products and increase your consump

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

tion of fish such as salmon.

Do you know how else yo

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

u will benefit from increased consumption of omega-3 fatty acids? Your cholesterol level will improve. You see, the essential omega-3 fatty acids have the ability to help decrease your total cholesterol and your LDL cholesterol level. The LDL cholesterol is the so-cal

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

Professional from academic institutions, pharmaceutical industries, health care indust

led bad cholesterol. So you will improve your cholesterol levels by adding a better balance of omega-3 fatty acids to your diet.

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

style="FONT-SIZE: 12pt; FONT-FAMILY: Arial; mso-bidi-font-size: 10.0pt"> Not surprisingly, the omega-3 fatty acids can be heart healthy. Several diseases show improvement when patients increase their intake of these essential fats. Check out Dr. Ray Strand’s impor

.

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

tant book for citings of clinical studies of omega-3. The book is titled, “What Your Doctor Doesn’t Know About Nutritional Medicine May Be Killing You.” It’s a wonderful book and should be a standard reference volume in your nutrition library.

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

Companies that provide selfless information through particip

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Eat well, take appropriate supplements, and stay 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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