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It's no secret that age-related macular degeneration is the leading cause of blindness among the elderly in industrialized countries. It affects more than 10 percent of white adults over the 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

ge of 80, and is the number one cause of central vision loss for people 60 years of age and older in the United States.

What is age-related macular degeneration? Just what its name suggests -

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

Examples of combination products may in

degeneration of the macula, which is located at the back of your eye in a tissue called the retina. Your maculae are what allow you to see fine details in the central portion of your field of

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

vision. This is why people with even the most advanced cases of macular degeneration do not experience total blindness - some peripheral vision is almost always maintained as long as there 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

n't a concurrent condition that affects peripheral vision.

Degeneration of the macula begins to occur when a protective layer called the retinal pigment epithelium (RPE) begins to break down.

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

Combination pro

In a healthy eye, the RPE acts as a protective filter that allows nutrients to pass through to reach the macula while preventing the passage of waste materials and other harmful substances.

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

As the RPE begins to break down, waste materials and other harmful substances can erode the macula. Thinning of the macula in this manner is what can precipitate blurred, dim, or distorted cen

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

ral vision, all of which are common initial symptoms of macular degeneration. This is also known as the dry phase of macular degeneration.

Sometimes, the damage that occurs with waste materia

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

ls coming into contact with the macula can cause significant inflammation, leading to the formation of tiny blood vessels and even causing leakage of tissue fluid into the area. This is also k

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

nown as the wet phase of macular degeneration.

As with most health conditions, it is impossible to know every single cause of macular degeneration. The retinal pigment epithelium (RPE) is lik

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

e any other group of cells in your body in that it can deteriorate due to any number of factors, the most common of which are:

* Consistent presence of incompletely digested chains of amino a

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

Following aspects would a

cids in your blood, which can trigger the production of antibodies, which can in turn, cause damage to the RPE

* Consistent exposure to significant amounts of exogenous (produced outside of y

dd to the challenges in developing combination products:

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

our body) toxins - for many women, cosmetics - especially lipstick and other facial make-up - are the most significant and dangerous source of exogenous toxins

* Regular production of endogen

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

ous (produced inside of your body) toxins due to poor digestion

* Regular consumption of unhealthy fats and oils

* Regular consumption of sugar and highly processed foods

* Emotional stress

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

* Regular exposure to first or second-hand cigarette smoke

Two Steps That Can Help To Prevent Blindness and Macular Degeneration

Clearly, the first step to preventing and treating ma

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

cular degeneration is to address each of the factors listed above.

The second step is to make sure that you are regularly eating healthy foods that provide an abundance of naturally occurring

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

Professional from academic institutions, pharmaceutical industries, health care indust

vitamins and minerals, particularly foods that are rich in vitamin C, vitamin E, beta carotene, and zinc.

Vitamin C, Vitamin E, beta carotene, and zinc have antioxidant properties that a rec

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

ent study in the Journal of the American Medical Association found to be especially effective in fighting the cellular changes that occur with macular degeneration. I was pleased to see that t

.

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

he study noted that "Foods high in these nutrients appear to be more important than nutritional supplements."

As with all other health conditions, I know of no short cuts to preventing and tr

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

Companies that provide selfless information through particip

eating age-related macular degeneration. The best way to prevent and treat macular degeneration is to take care of your overall health while paying special attention to the points listed above

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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The World Community needs to awake up to save the glaciers from melting. Siachen, still a bone of contention between two countries, needs to be adopted by the World Community. With the life of 400million people, living within 20 m of sea level or within 20km of the coast lines, affected by the rising sea, the Himalayan Glaciers and Siachen need to declared as a GLOBAL HERITAGE.

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