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LASIK surgery works by changing the shape of your cornea, that translucent covering over your pupil and iris (the colored ring in your eye). A successful procedure will

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

result in a cornea that bends light rays, in a process called "refraction." This focuses them more accurately on your retina, the "back wall" or "screen" on which images

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

Examples of combination products may in

are projected. LASIK corrects the shape of the cornea so it is properly focused at that point, instead of another point either in front of - or behind - your retina.

T

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

he development and continuing refinement of LASIK eye surgery has been bringing better, clearer vision to millions of people who once had to rely on glasses or contact l

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

enses. With decades of experience and ongoing advances in the underlying technology, the safety and efficacy of the LASIK procedure is now well established. Of course, c

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

Combination pro

omplications associated with laser eye surgery still exist. so it is critically important for you to find out what the procedure involves, what can possibly go wrong and

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

whether or not you are a good candidate for it.

LASIK may be a viable option for you if you are nearsighted, farsighted or have some forms of astigmatism, all of which

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

are called "refractive errors." Nearsightedness means that the eyeball is somewhat longer than normal, or the cornea curves too much, which results in blurred distant v

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

ision as the light focuses in front of the retina. Farsightedness occurs when a "short" eyeball, or a cornea that is "too flat" focuses light behind the retina, blurring

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

near vision (and sometimes distant vision too). Finally, astigmatism affects the focus of both near and distant vision if the cornea either curves and/or flattens uneve

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

nly.

Most eye doctors will probably recommend other types of vision correction before turning to LASIK eye surgery or a related procedure. Naturally, wearing glasses or

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

Following aspects would a

contact lenses is the first alternative. As opposed to other eye diseases, these refractive errors are not necessarily progressive conditions, and may actually get bett

dd to the challenges in developing combination products:

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

er in middle age for some people. And there are some doctors who reject the need for LASIK eye surgery, claiming that your eyes are still healthy even with nearsightedne

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

ss or farsightedness. The best approach for you is something that you will have to decide after a complete, careful evaluation of your eyes, your overall health and your

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

expectations for the surgery.

Part of the process of determining if you're a candidate for LASIK eye surgery involves considering the particular risks it presents for

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

some people. Your LASIK surgeon may advise you against this surgery if you have an immune system disease that reduces your capacity to heal after surgery. With an "autoi

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

Professional from academic institutions, pharmaceutical industries, health care indust

mmune disease" like rheumatoid arthritis, or an "immunodeficiency disease" such as HIV, the risk of infection and other complications following laser eye surgery is grea

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

ter.

Other conditions that may affect your suitability for the LASIK procedure are conditions that cause dry eyes, as they are likely to obstruct and delay the healing

.

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

process. Doctors report that extremely uneven or abnormally shaped corneas may complicate matters, and if your vision is progressively worsening from other conditions yo

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

Companies that provide selfless information through particip

u may be considered ineligible for laser eye surgery. In fact, even deep-set eyes and other facial-bone anomalies can make the procedure both riskier and more difficult.

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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Management is often considered to be a two dimensional task-based deliverable. Technical management has long been viewed this way, with the delivery of the technology as the priority and the people as the methodology of delivery. The opportunity to make it interesting, fascinating and three dimensional is in the vision contribution and compliance.

If you are a small business owner, isn't it time to stop trying to do it all yourself? Think about outsourcing this important job and free up your time to do what you do best- run your business.

By the age of 50 more than 1 in 4 women are still single. These 8 reasons explain why they haven't met their man and what you can do to discover which reasons are preventing you finding your Mr. Right

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