Advice Pool - Health and Fitness

A study published in Lancet Neurology, a monthly UK medical journal, suggests that Vitamin E gained from dietary sources may

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

help Parkinson’s disease.

The study was conducted by Dr. Mayhar Etminan and colleges from Queen’s University in Canada. This

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

Examples of combination products may in

team of researchers measured data from eight studies previously published between the years 1966 and 2005, in hope of determ

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

ining whether vitamins E, C and the nutrient beta carotene, have any effects on Parkinson’s Disease.

Parkinson's disease is

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

a degenerative disorder that affects the central nervous system. It can be characterized by tremor, rigidity and a slowing, o

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

Combination pro

r complete loss, of physical movement. It may also cause cognitive dysfunction and language issues.

Parkinson’s disease is o

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

ftentimes hard to diagnose and although it has no cure, medications and surgery can provide some relief from symptoms.

The s

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

tudy concluded that although vitamin C and the nutrient beta carotene didn’t seem to have any effect on the disease, it appea

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

red that moderate and high amounts of vitamin E consumed through one’s diet did have a positive effect and seemed to help pro

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

tect against the development of the disease. Although to be sure, a controlled study with subjects, instead of simply data, w

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

ill need to be held to determine if these results can be confirmed.

Vitamin E is a fat-soluble vitamin and a powerful antiox

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

Following aspects would a

idant that protects against cell damage caused by free radicals. The recommended daily intake of vitamin E from food is 15 mi

dd to the challenges in developing combination products:

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

lligrams. Vitamin E deficiency is rare in humans, yet there have been studies suggesting that too much vitamin E, usually gai

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

ning through supplementation, can be dangerous.

Green leafy vegetables, nuts and vegetable oils are the main dietary sources

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

of vitamin E, such as spinach, almonds, kale, broccoli, turnip greens, peanuts, avacado, olive oil, wheat germ and safflower

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

oil.

Although the study was an interesting find, it is still too early to tell whether vitamin E

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

Professional from academic institutions, pharmaceutical industries, health care indust

://www.vitaminstuff.com/supplements.html>health supplements would have the same affect as natural, dietary vitamin E.

Ex

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

perts are warning against people buying vitamin E supplements to help ward off the disease, especially since too much vitamin

.

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 can be toxic (fat soluble vitamins are more likely to achieve toxi

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

Companies that provide selfless information through particip

city than water soluble vitamins).

More studies will be held to determine if vitamin E can actually help Parkinson’s disease

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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