E-Articles - Health and Fitness

Many people are prone for eye injuries especially the children while playing an

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

d agricultural and factory workers who are engaged in different type works.

Ey

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

Examples of combination products may in

lashes usually protect the eyes from direct injuries. But sometimes eye injuri

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

es do occur piercing the defense of the eye. Sharp wooden or metal pieces enter

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

and damage the eyes. This usually happens to workers, who work in quarries and

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

Combination pro

in metal works. Various organic substances like acids and alkalis may fall acci

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

entally into the eye and cause mild to severe damage. Apart from sharp objects,

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

blunt objects also can damage the eye and cause blindness.

Damage to the eyes

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

depends on 1) The sharpness of the accident. 2) The infection carried due to in

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

jury. 3) The infection of the iris- iritis. 4) The injury of one eye may cause

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

amage to the other eye. Usually the sharp objects tear the cornea or the whi

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

Following aspects would a

ter sclera. In these situations, the iris which is inside might pop up and get

dd to the challenges in developing combination products:

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

rapped in the wound. The trapped iris might cause infection and damage the whol

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

e eye. Treatment at this stage would be surgery. The popped out iris has to be

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

cut and the cut portions of cornea and sclera have to be sutured with fine sutu

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

res. If the cut portion is only in the sclera, the visual damage would be less.

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

Professional from academic institutions, pharmaceutical industries, health care indust

If the damage is more in the cornea, the visual damage would be more, with the

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

result that such eye would become partially or completely blind. The success

.

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

f the treatment depends on the early institution of the correct and proper trea

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

Companies that provide selfless information through particip

tment. So it is necessary to consult a competent Eye specialist at the earliest

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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