Full of Articles - Health and Fitness

Like many people, you may be asking "what is homocysteine" and wondering how it could increase your risk of having Alzheimer's Disease. Homocysteine is an amino acid produced naturally by the body, but too much homocysteine in the blood is toxic a

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

nd can lead to damage and blockage of the arteries and blood vessels.

This makes elevated homocysteine levels a risk factor for vascular disease like heart disease and stroke. During the last ten years research has revealed a possible connection

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

Examples of combination products may in

between vascular disease and the Alzheimer's Disease and other kinds of dementia. "The New England Journal of Medicine" recently published a study that indicates that elevated levels of homocysteine may itself may increase older people's risk of A

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

zheimer's Disease and other forms of dementia.

About the study: A group of researchers at Boston University and Tufts University in Boston began studying a subgroup of participants of the Framingham Study during the period between 1986 and 1990.

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

The Framingham Study participants had been having complete physical exams and answering lifestyle questionnaires every two years since 1948. The subgroup was comprised of 1,092 men and women with an average age of 76. Participants in the subgrou

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

Combination pro

were all free of any dementia at their 20th biennial exam. These occurred between the years 1986 and 1990. Blood homocysteine levels were checked at both the 20th and 16th biennial exams,

Participants of the subgroup underwent additional tests b

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

eyond those required by the Framingham Study protocol. Each participant of the subgroup had tests for dementia during the biennial exam from 1986 to December 2000. The results were evaluated by two neurologists and a neuropsychologist. Each partic

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

ipant was also tested for an apolipoprotein E gene - a known risk factor for Alzheimer's Disease.

The participant's medical records were reviewed by researchers form their 20th biennial exam through December 2000 along with their homocysteine mea

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

urements recorded from their 16th biennial exam. They were specifically looking at how homocysteine blood levels correlated with Alzheimer's Disease or other dementia.

Research findings: It was found that an increase of 5 micromoles of homocyste

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

ine per liter of blood increased the risk of Alzheimer's Disease by 40%. People with the highest levels of blood homocysteine had almost double the risk of Alzheimer's and other dementia as compared to people with lower blood homocysteine. This de

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

ermination was made after accounting for other risk factors.

It is important to note that the statistics held true for homocysteine levels from both the 16th and 20th biennial exams. Since Alzheimer's Disease develops slowly, it may be the diseas

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

Following aspects would a

e process had begun in some study participants at the 20th biennial exam but was not yet measurable. It would be very unlikely the participants were really free of disease at the 16th biennial exam, eight years prior.

What does this mean to you?

dd to the challenges in developing combination products:

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

We do know that elevated homocysteine levels may increase the risk of heart disease and stroke. The study finding now suggest that elevated homocysteine levels may also increase our risk of Alzheimer's Disease and other conditions of dementia as

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

e age. However, they didn't go as far as proving elevated homocysteine levels an indicator of future Alzheimer's Disease. The participants age ranged from 68 years to 97 years which makes it unclear whether younger adults might be at increased ris

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

k of Alzheimer's later in life if they have elevated homocysteine levels.

Having said that, several other studies do suggest that keeping homocysteine levels in check may help prevent blood vessel damage and prevent atherosclerosis (hardening of

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

he arteries). The good news is that it is easy to keep your homocysteine levels in the safe range.

Vitamin B-12, folic acid and vitamin B-6 when taken in food or supplements has been shown to reduce homocysteine levels in the blood. Although we d

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

Professional from academic institutions, pharmaceutical industries, health care indust

on't yet know if this will also reduce the risk of Alzheimer's Disease, the known benefits make it worthwhile to make sure you obtain adequate supplies of these nutrients through diet and supplementation. Foods containing folic acid include:

* F

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

ruits and orange juice from concentrate * Green, leafy vegetables * Dried beans and legumes * Liver * Grain products that have been fortified with folic acid, such as cereal, pasta, rice, and bread

Foods containing Vitamin B-12 include:

* Li

.

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

er and other meats such as pork and beef * Eggs * Milk and other milk products

Vegetarians should note: they must supplement to get their vitamin B-12 as fruits and vegetables contain no vitamin B-12.

REFERENCES: Seshadri S, et al. "Plasma ho

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

Companies that provide selfless information through particip

mocysteine as a risk factor for dementia and Alzheimer's Disease", "New England Journal of Medicine", February 14, 2002;346(7):476-483. Loscalzo J., "Homocysteine and dementias", "New England Journal of Medicine", February 14, 2002;346(7):466-468

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.fullofarticles.org.ua/article/230158/fullofarticles-Do-Elevated-Homocysteine-Levels-Increase-Risk-For-Alzheimers-Disease.html">Do Elevated Homocysteine Levels Increase Risk For Alzheimer's Disease?</a>

BB link (for phorums):
[url=http://www.fullofarticles.org.ua/article/230158/fullofarticles-Do-Elevated-Homocysteine-Levels-Increase-Risk-For-Alzheimers-Disease.html]Do Elevated Homocysteine Levels Increase Risk For Alzheimer's Disease?[/url]

Several considerations for an effective customer service program as part of core strategy to serve customers well.

Everyone wants to increase the number of subscribers they have and are constantly planning new strategies to do so. One very effective tactic to attract subscribers is to offer them freebies along with the subscription. These freebies could be in any form such as, premium or a bonus item etc.

Several major sub prime lenders have recently discontinued business and/or curtailed loan origination. This is creating risks in the mortgage market . We have outlined several reasons why more of these lenders are now at risk.

Tags

Links

Full of Articles - Do Elevated Homocysteine Levels Increase Risk For Alzheimer's Disease?

Related Articles: