Advice Pool - Health and Fitness

If, like most of us, you wear glasses or contact lenses, the possibility of having good eyesight without them may seem remote. For years you have been stuc

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

k with only these two options—or a third, of not seeing very well.

Today, Lasik eye surgery is all you ever hear about and you probably know several people

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

Examples of combination products may in

who have already been through the process. They just rave over how quick and easy the process was and that they do not have to be bothered wearing glasses

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

or taking care of contact lenses. And, you are seriously considering doing the same thing. But, are you a good candidate for this surgery?

The best way t

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

find out if you are a good candidate is to schedule an appointment with an eye surgeon and have an examination. There are certain standards that your eyes

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

Combination pro

must meet in order to be considered for the surgery. They are:

* A correctly sized pupil,
* A cornea of the right thickness,
* A cornea that is

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

structurally normal (not an unusual shape),
* Have a healthy pressure within the eye, and
* Have basically healthy eyes (with no diseases or injur

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

ies that might interfere with the surgery).

Okay, you are ready to go. You have received your eye examination and have been approved for the procedure by

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

he eye surgeon. Now what? You schedule a date and show up at the appropriate time. You know that you will be awake for the procedure and everything has b

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

een carefully explained. Now, it is time to prep for the surgery.

You are finally in the laser suite where you will be positioned comfortable on your back

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

under the excimer laser. Your surgeon will put anesthetic eye drops in your eyes to numb their surface. The eyelashes are taped out of the way and an eyel

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

Following aspects would a

d speculum is placed between you eyelids to keep you from blinking.

Small reference marks are put on your cornea to serve as positional guides for replacin

dd to the challenges in developing combination products:

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

g the corneal flap. A suction ring is placed on your eye to hold it is position and to maintain the pressure within. The corneal flap is now created and f

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

lded back. The next step is for the laser procedure to sculpture the cornea by vaporizing small amounts of tissue-this step can take anywhere from 20-90 se

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

conds to complete. The eye is then flushed out to remove any debris and then the corneal flap is put back into its original position.

You will be asked to

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

sit quietly with your eyes closed for about 30 minutes and then the eye surgeon will come back and check to make sure that everything is all right. You may

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

Professional from academic institutions, pharmaceutical industries, health care indust

have a sensation that there is something in your eye, but this will pass. When it is time to go home, you will be given antibiotic drops, anti-inflammator

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

drops, and lubricating eye drops along with a detailed set of instructions on what to do and when to do it. In addition, you will schedule several postope

.

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

rative appointments to have your doctor check on your eyes.

Now, you know the basics. If you are considering lasik eye surgery, make sure that you do your

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

Companies that provide selfless information through particip

research and find the best eye surgeon in the area. Once everything is completed, you will enjoy the freedom of not dealing with glasses and contact lenses

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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Advice Pool - Thinking About Lasik Eye Surgery?

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