E-Articles - Health and Fitness

LASIK is the latest type of refractive surgery. As the name implies, refrac

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

tive surgical procedures are used to alleviate refractive errors. Refractiv

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

Examples of combination products may in

errors are imperfections in the eye’s focusing power.

Making the decision

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

to get a LASIK is no laughing matter. Before submitting to the proc edure,

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

you should gather as much information as you can. This will help you evalua

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

Combination pro

e the risks that come with LASIK treatment.

If you are not a risk taker, t

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

en LASIK is probably not for you. Although the procedure is relatively safe

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

, it is also quite new. There is no long-term data available for LASIK pati

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

nts. Complications after the operation are definite possibilities, though t

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

ey are not likely.

LASIK can also jeopardize your career. Some career path

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

may close to you once you get refractive surgery. Before you do, you might

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

Following aspects would a

want to clarify the issue with your superiors. Cost is also an issue. Ref

dd to the challenges in developing combination products:

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

active surgery is usually not covered by insurance, which can mean high cos

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

s for you. Those who participate in contact sports such as boxing and wrest

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

ling are also poor candidates for LASIK.

Anyone who still exhibits refract

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

ve instability may also be bad candidates for LASIK. Younger patients, such

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

Professional from academic institutions, pharmaceutical industries, health care indust

as those under age 25, can expect their cornea to change significantly over

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

the course of their life. As such, the effects of LASIK or any other refra

.

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

tive surgery might vary over time. People who exhibit refractive instabilit

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

Companies that provide selfless information through particip

may also include the diabetes patients and pregnant or breastfeeding women

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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