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If you are one of millions of people who suffer form some kind of vision problem, you are probably already using some kind of vision correction aid - such as gl

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

asses or contact lenses.

You have also probably heard of the Lasik eye surgery. Lasik is actually a group of surgical procedures that are carried out

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

Examples of combination products may in

in order to correct near- and far-sightedness in vision.
Many patients undergo a LASIK surgery as an alternative to wearing corrective glasses or contac

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

t lenses. But you should know that while procedures such as LASIK have the ability to provide acute vision there is no way to quantify the quality of vision the

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

patient will have after the surgery.

The operation itself involves peeling thin layers from the patient's cornea, using precise laser technology. The

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

Combination pro

pealing of this layer corrects the imperfection in the patent's cornea thus giving them the vision correction that is usually provided by their glasses or cont

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

act lenses.

In preparation to the surgery, a patient who wears soft contact lenses will be asked to stop wearing them 10 days before the surgery. User

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

s of hard contacts are instructed to stop using them six weeks before the surgery.

Before the surgery, the patient's cornea surface are scanned with

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

a special computer and their pattern is recorded.This will provide the doctor with precise information on how much tissue should be removed during the operation

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 patients is also instructed to start taking anti-biotic to reduce the risk of infection.

The surgery itself is performed under a mild sedative (

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

uch as Valium) and anesthetic eye drops. After the procedure, the patient is given a course of antibiotic and anti-inflammatory eye drops.

Patients a

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

Following aspects would a

re also given a darkened pair of goggles to protect their eyes from rubbing when asleep. It is advised to wear these from four to eight weeks depending on the n

dd to the challenges in developing combination products:

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

ature of the surgery.

So, if a quick Lasik surgery can rid you of our glasses for good, why aren't all glasses wearing people go to a clinic and get i

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

t done?

Like almost all medical procedures, Lasik surgery has some disadvantages and complications. First of all, a good Lasik surgery can cost a heft

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

y sum, and not all health insurances will cover the costs (some will cover only part of the costs). And second, there are complication that are associated with

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

this procedure. About %3-%6 of patients tend to suffer from one or more of the following complications:

Dry eyes
Over correction or under correc

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

Professional from academic institutions, pharmaceutical industries, health care indust

tion
Visual acuity fluctuation
Halos or star bursts around light sources at night
Light sensitivity
Ghosts or double vision
Wrinkl

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

es in flap
De centered ablation
Debris or growth under flap
Thin or buttonhole flap
Induced astigmatism
Epithelium erosion

.

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

Posterior vitreous detachment

As you can see, this procedure is not problem free. Before undergoing such a procedure, ask yourself if the glasses you

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

Companies that provide selfless information through particip

wear as so bad that you are willing to do this operation to get rid of them. If the answer is less than a resounding "yes", you better reconsider this operation

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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