Advice Pool - Health and Fitness

A clinical trial that showed that vitamin E slowed the progress of some consequences of Alzheimer’s disease by about 7 months has been discounted by recent

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

studies.

Another clinical trial is examining whether vitamin E and/or selenium supplements can prevent Alzheimer’s disease or the cognitive decline associa

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

Examples of combination products may in

ed with the disease. Ongoing research and clinical observations involving other antioxidants are being planned.

Some studies that claimed hormone replac

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

ment therapy, NSAIDs (nonsteroidal anti-inflammatory drugs) and antioxidant vitamins as promising treatments in preventing or slowing Alzheimer's disease in

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

dicate that they do not.

Qi Dai, M.D., Ph.D., Assistant professor of Medicine, conducts ongoing research on causative and preventative measures for Alzheim

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

Combination pro

r's Disease. The research is supported by grants from the National Institutes of Health. Dai and his research team began to suspect that perhaps another c

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

ass of antioxidant chemicals, known as polyphenols, could play a role in preventing or slowing down of Alzheimer’s disease.

Polyphenols are non-vitamin ant

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

ioxidants common in the diet and particularly abundant in teas, juices and wines. Polyphenols exist primarily in the skins and peels of fruits and vegetable

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

. Recent studies have shown that they extend maximum lifespan by 59 percent and delay age-dependent decay of cognitive performance in animal models.

Food s

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

urces rich in polyphenols include onion, apple, tea, red wine, red grapes, grape juice, strawberries, raspberries, blueberries, cranberries, and certain nut

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

"Also, animal studies and cell culture studies confirmed that some polyphenols from juices showed a stronger neuroprotective effect than anti

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

Following aspects would a

oxidant vitamins. So we are now looking at polyphenols," Dai said.

At the 2nd International Conference on Polyphenols and Health held at the

dd to the challenges in developing combination products:

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

niversity of California campus in Davis October 4-7, 2005, the health effects of Polyphenols was discussed by a broad range of researchers and scientists.

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

here were global representatives that attended to hear the scientific presentations and discussions on the health effects of polyphenolics.

Some of the fin

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

dings concluded that there are clear effects of polyphenols on established surrogate markers of cardiovascular diseases. Also the discussions centered on t

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

e biological effects involved in the protective effects of polyphenols against cardiovascular diseases, on different body tissues, i.e., blood vessels, hear

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

Professional from academic institutions, pharmaceutical industries, health care indust

muscles, etc.

There was a clear consensus that antioxidant activity is not directly related to any health effects, but is simply a biomarker for the prese

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

nce of polyphenolics, a marker that can be confounded by constitutive antioxidants.

The beneficial effects of phenolics now appears to be its effects on ce

.

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

l signaling and several speakers made this point at the conference. Researchers called for a clear, clinical demonstration of a human health benefit from p

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

Companies that provide selfless information through particip

lyphenolics.

Researches are conducting more clinical trials to check blood polyphenol levels to see if high polyphenols correlate with low Alzheimer's risk

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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