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I can still remember that fateful day. I lay in bed, ready to get into my favorite book and it appeared that someone put a dimmer b

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

ulb in the bed lamp. Nope! Turns out that the head lamps were going dim a lot longer than I was aware of. It is fact of life that a

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

Examples of combination products may in

fects many of us and for me; it was around my 40th birthday. It wasn’t enough that I was going over the hill, its out I was having

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

hard time even seeing the hill.

So why Lasik and why is it so popular? LASIK has advantages over other procedures, including a re

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

ative lack of pain afterward and the fact that good vision is usually achieved by the very next day.

LASIK is the most commonly pe

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

Combination pro

formed refractive surgery procedure. You may hear people calling it "LASIX," but the name is actually short for "laser-assisted in

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

itu keratomileusis."

An instrument called a microkeratome is used in LASIK eye surgery to create a thin, circular flap in the corn

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

a. Another, newer way of making the flap is with a laser. Read more about the recently developed IntraLase laser that is used for t

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

is purpose.

The way the procedure works is that the surgeon folds the flap back out of the way, and then removes some corneal tiss

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

e underneath using an excimer laser. The excimer laser uses a cool ultraviolet light beam to precisely remove ("ablate") very tiny

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

its of tissue from the cornea to reshape it. When the cornea is reshaped in the right way, it works better to focus light into the

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

Following aspects would a

eye and onto the retina, providing clearer vision than before. The flap is then laid back in place, covering the area where the cor

dd to the challenges in developing combination products:

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

eal tissue was removed.

Both nearsighted and farsighted people can benefit from the LASIK procedure. With nearsighted people, the

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

oal is to flatten the too-steep cornea; with farsighted people, a steeper cornea is desired. While this is not widely recognized by

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

consumers, excimer lasers also can correct astigmatism by smoothing an irregular cornea into a more normal shape.

California Lasik

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

eye surgery, which can cost thousands of dollars and will not be covered by most insurance companies, grew in popularity during the

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

Professional from academic institutions, pharmaceutical industries, health care indust

1990s but slowed amid the 2001 recession. The numbers are slowly rising again, but some patients are squeamish about having blades

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

nserted into their eyes, experts say.

The bottom line is LASIK surgery is becoming more common place. The number of surgeries perf

.

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

rmed each year is in the thousands and has become an extremely safe procedure. The best bet is to contact your personal physician,

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

Companies that provide selfless information through particip

ave him connect you with an eye specialist that will examine you and give the best possible advice to see if LASIK is right for you

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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