E-Articles - Health and Fitness

Lasik surgery allows many people to escape wearing contact lens and/or glasses, even if they’ve worn them all of their

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

lives. It is used in the treatment of refractive vision problems. The word Lasik means laser assisted in situ keratom

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

Examples of combination products may in

ileusis. It is a very popular form of treatment today because there is little pain associated with it and because it p

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

roduces good results. It is a quick form of surgery taking about fifteen minutes per eye. Lasik surgery is only good f

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

r three forms of vision problem. Myopia is knows as near-sightedness. This means that the light is refracting is such

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

Combination pro

a way that distant objects are blurry. Hyperopia or far-sightedness is the opposite. People can’t focus clearly on n

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

ear items, but their distance vision is fine. Astigmatism is a focusing problem that results in blurred vision.

The L

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

asik procedure is rather simple. The patient’s eyes are examined prior to surgery and are measured and mapped. This a

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

lows the physician to determine the correct amount of tissue to remove. The surgery takes place with the patient awake

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

. The physician begins by making a flap in the covering of the eye. This can be accomplished with a knife or with a l

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

aser. The laser, which is generally preferred by patients, is directed by a pre-programmed computer to make the flap.

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

Following aspects would a

Once the flap is made it is pulled back to reveal the cornea. The physician uses a different laser to remove corneal t

dd to the challenges in developing combination products:

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

ssue. The amount to be removed is determined by the pre-surgery design and eye mapping. When this is finished the flap

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

is put back in place and the eye heals. Most patients have an immediate improvement in their vision although it may t

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

ake up to six months before the full effects are known. The result is often perfect or near perfect vision for the pat

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

ient who no longer needs glasses or contact lens. The laser reshapes the cornea. This causes the light to refract dif

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

Professional from academic institutions, pharmaceutical industries, health care indust

erently through the eye to the retina correcting one, two or three of the vision problems discussed above. This is usu

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

ally a permanent solution to these problems. People who have Lasik surgery throw away their glasses and contact lens f

.

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

or good.

Lasik surgery is rarely covered by insurance although some plans are beginning to cover some of it. Check ar

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

Companies that provide selfless information through particip

ound when looking for a physician to perform the Lasik surgery. The clinic closest to your house is not always the best

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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