Advice Pool - Health and Fitness

Lasik eye surgery is a procedure for which many of us are candidates. Using laser technology to modify the surface of our cornea allows for a great improveme

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

nt in vision; and often frees us from the expense and inconvenience that comes with eyeglasses and contact lenses.

This procedure is done so frequently – an

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

Examples of combination products may in

on such a wide scale – that people tend to forget that ultimately it is a surgical procedure that should be given the same consideration as any other type o

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

surgery. So when it comes to choosing a Lasik eye center, the decision should be made with a number of different factors in mind.

Lasik surgery uses laser

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

echnology to resurface the cornea – the thin layer of transparent tissue that covers the iris and lens in our eye. The lens actually sits behind the iris – t

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

Combination pro

e colored part of our eye – and receives the light that we see all around us in the form of images. The lens refracts – or bends – the light to the retina –

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

a group of cells that line the back of the eye. The retina then takes these light signals and converts them to messages that can be received by the optic ner

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

e in our brain.

When we suffer refractive difficulties – through nearsightedness, farsightedness, or astigmatism – the light is not refracted properly and t

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

e brain receives a message of a blurry image. During refractive surgery – such as Lasik – the appropriate corrections are made in order to refract light prop

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

rly.

A Lasik eye center performs Lasik surgery on a daily basis. During the procedure, the patient’s eye is numbed, held open with a speculum, and immobiliz

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

d using a cornea suction ring. Once the eye is held steady, the surgeon makes a thin incision in the top layer of the cornea to create a flap. The flap is th

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

Following aspects would a

en folded back to reveal the mid-section of the cornea – known as the stroma.

This is the part that is resurfaced using laser technology. Once the resurfaci

dd to the challenges in developing combination products:

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

g has been completed, the flap is returned over the eye and allowed to heal naturally. Most people who have Lasik report success through much improved vision

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

But achieving successful results relies most heavily on finding a reputable Lasik eye center.

First and foremost, no decision should be made at all about L

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

sik until you are absolutely certain that you are a candidate for the procedure. Only your eye doctor can make that determination so you should begin this pr

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

cess with a comprehensive examination by your ophthalmologist who can tell you which procedure will work best for you and what Lasik eye center to visit. If

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

Professional from academic institutions, pharmaceutical industries, health care indust

your doctor is someone whom you trust then this is the best recommendation that you can get for a Lasik eye center.

It is also advisable to speak with other

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

patients who have undergone Lasik eye surgery. Not only will you learn about their experience with a particular Lasik eye center but you will learn what to e

.

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

pect from the procedure in general. Do not underestimate the power of your peers. Listen to what they have to say about their doctors, how they were treated,

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

Companies that provide selfless information through particip

the professionalism of the Lasik eye center staff, their comfort during the procedure itself, their recovery time and experience, and, finally, their results

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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