Summary - Health and Fitness

Vitamin A is required for night vision and maintenance of body linings and skin. Because of its antioxidant properties, it assis

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

ts the immune system, and is good to protect against cancer formation and other diseases. It also helps the digestive and urinary tract as

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

Examples of combination products may in

well as assisting your sense of taste. Many scientific studies suggested that it helps slow aging.

A deficiency of vitamin A may cause ey

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

problems with dryness of the cornea and conjunctiva and night blindness. A warning of too little vitamin A in the body are dry itchy eyes

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

that tire easily. If the vitamin A deficiency is severe, the cornea can ulcerate and leading to permanent blindness.

A vitamin A deficienc

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

Combination pro

may also lead to dry skin and hair, especially if protein is also lacking.

Vitamin D (calciferol) can rightly be called the su

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

nshine vitamin, since the body can manufacture this nutrient from sunshine on your skin using cholesterol from your body to do so.

Vitamin

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

D helps with increasing the absorption of calcium, promotes strong teeth and generally assists in bone growth and their integrity.

A lack

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

of vitamin D can lead to softening of the bone and muscle twitching and convulsions. In children it causes rickets. In adults, the shortage

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

causes osteomalacia - loss of minerals from the bones. In older people, when protein is also lost from the bone. osteoporosis may be a pr

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

blem.

Vitamin E has earned itself a reputation - from spicing up your sex life to banning wrinkles and old age.

A powerful ant

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

Following aspects would a

ioxidant, Vitamin E is protects body cells from oxidation, and neutralizes unstable free radicals, which can cause damage. Its antioxidant

dd to the challenges in developing combination products:

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

capability is a great help in preventing degenerative diseases - such as heart disease, strokes, arthritis, senility, diabetes and cancer.

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

Shortage of Vitamin E is not common, and the symptoms not very clear cut, but they may include inflamed varicose veins, fatigue, premature

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

aging, wounds healing slowly and sub-fertility.

Vitamin K is used in the body to control blood clotting and is essential for s

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

nthesizing the liver protein that controls the clotting.

A deficiency of this vitamin may manifest itself in nosebleeds, internal hemorrha

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

Professional from academic institutions, pharmaceutical industries, health care indust

ging. In newborn babies, lack of vitamin K results in hemorrhagic disease, as well as postoperative bleeding and hematuria.

As you can see

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

the above vitamins are very important for your body and any deficiency must by a adjusted. But there is a problem here. Vitamins A, D, E a

.

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

d K are classified as a fat-soluble vitamins and they are not excreted as readily as water soluble vitamins (such as the B vitamins and vit

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

Companies that provide selfless information through particip

amin C). Once absorbed, Vitamins A, D, E and K remain stored in the liver and fatty tissues, therefore excess intake can cause toxic buildu

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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