Advice Pool - Health and Fitness

You know a lot of people who have already had lasik surgery, but you are not sure that it is right for you. What do you need to know before mak

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

ing an informed decision? Start with a good eye surgeon and set up an appointment for an examination. The doctor will be able to tell you whet

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

Examples of combination products may in

er or not you are a good candidate for lasik surgery.

There are many reasons why you may not be a good candidate and the doctor will explain th

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

ese to you. Listen to him carefully and know that he has your best interest in mind. You may find that you have:

* An unstable prescription -

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

this means that your eye condition changes regularly.
* A severe refractive error -- to correct your extreme nearsightedness or farsighted

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

Combination pro

ness, it will require too much deep sculpturing and cornea reshaping.
* Large pupils -- if the pupil is too wide, then the laser beam will

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

ot be able to properly shape the eye.
* A thin cornea will not retain its structure and shape if the top layers of tissue are surgically

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

removed.
* Abnoramally structured cornea -- this condition is not treatable with Lasik surgery.
* Pregnant or nursing -- these two con

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

itions may change the measured refraction in your eye.
* Collagen vascular disease -- affects the collagen-containing connective tissue.

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

> * Glaucoma or cataracts. These eye diseases may cause complications for laser surgery.
* Active herpetic keratitis -- a herpes infectio

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

in the eye.
* Diabetic retinopathy -- a potentially blinding complication of diabetes.

These are just a few of the reasons why you may no

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

Following aspects would a

t be a candidate for lasik surgery. You should be honest with the doctor and work with him and his staff to make sure that you have no hidden p

dd to the challenges in developing combination products:

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

oblems.

Make sure you go to a reputable eye surgeon and not a small medical center that may disappear in a few years. Check into their credent

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

ials-how many lasik surgeries have they performed, were there any malpractice suits against them, and ask the Better Business Bureau about them.

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

The eyes you have are the only ones you get-a medical error would be disastrous.

You probably know someone who has already had the procedure d

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

one. Talk to them and see what they have to say-they have first-hand experience about what to expect and they may or may not recommend their ey

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

Professional from academic institutions, pharmaceutical industries, health care indust

surgeon.

If everything is okay, you will have your lasik surgery and go through your recovery period. It will take a few weeks for a complete

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

recovery, but your eyes should get stronger and your vision clearer.

Take your time, think about your options and then make an informed decisi

.

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

n about your lasik surgery. You may end up with 20/20 vision and never have to wear glasses or contact lenses again. Or, you may find out that

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

Companies that provide selfless information through particip

you do not qualify for this surgery. Either way, you took the time to learn about the procedure and are a more informed consumer because of it

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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