Advice Pool - Health and Fitness

The Lasik surgery procedure doesn't take much time, just a few minutes in fact, and it can be used to help people who suffer from nearsightedness, farsightedness

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

or astigmatism.

A traditional instrument used in Lasik is called a "microkeratome", and what is does is create a very thin circular flap in the cornea. Nowadays, this

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

Examples of combination products may in

step is performed by using a laser instead (thus the term laser surgery). In the next stage of the procedure, the surgeon will fold the flap back and remove some tissu

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

es of the cornea underneath this flap using an excimer laser. The excimer laser removes a very thin layer of the corneal tissue to reshape the cornea, by producing a co

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

l ultraviolet light beam.

A computer will already have determined the amount of layers to be removed from the cornea, and this level is calculated from the required fo

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

Combination pro

cus of the light through the eye and onto the retina, to achieve the required vision. The operation is concluded by the surgeon flipping the flap backwards in its previ

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

ous place, covering the area of the layers of corneal tissue now removed. The changes made to the cornea will depend on the problem being addressed. For nearsighted pe

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

ple the target is to flatten the too-steep cornea, while for the farsighted people the target is logically the exact opposite - to steeper the cornea. When correcting a

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

stigmatism the surgeon will smoothen the irregular cornea into a normal shape.

As there are some cases where it might be risky or even impossible to undergo the Lasik

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

surgery procedure, the patient will have an examination for the eyes before the surgery - in order to determine their health and the possibility of moving on to the su

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

gery. Part of the examination have the ophthalmologist using a slit lamp (or refractor) to examine the retinal problems. He also uses a tonometer in to determine the in

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

Following aspects would a

traocular pressure. Too high pressure for example, may be indicative of glaucoma (damage to the optic nerve).

Another part of the pre-surgery examination is the hydrat

dd to the challenges in developing combination products:

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

ion of the eye, to rule out any dry eye disease. Because this type of disease needs to be solved before the Lasik can be performed. A corneal topographer is then used t

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

o photograph the eye, creating kind of a map of the cornea. Nobody has a perfectly rounded cornea - the task of the topographer is to reveal the corneal irregularities,

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

such as steepness or flatness, which the surgeon will rectify during the surgery. As the technology has evolved, there are a new technique for this stage as well. These

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

are referred to as "wave front devices", and they work by sending waves through the eye to in order to give a more precise map of the corneal irregularities that affec

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

Professional from academic institutions, pharmaceutical industries, health care indust

t your vision.

Before the procedure, the surgeon should also ask questions about your general health, as specific health problems or taking certain medications may aff

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

ct the surgery, or result in other dangers to your overall health. If you are aware of any special health condition, you should inform your doctor about it openly, and

.

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

he can then determine whether it is safe to undergo this operation, or if it would be better to wait or call the whole thing off.

By reading basic information on the L

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

Companies that provide selfless information through particip

asik surgery procedure, you can get a pretty good picture if you an go through with the surgery. However, the decision will always be approved and finalized by a doctor

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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