Advice Pool - Health and Fitness

Lasik eye surgery is still relatively new and while thousands of people have enjoyed the benefits from this type of surgery, it still remains a mystery

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

to many. Questions such as how do I qualify? Is it safe; and what techniques are employed are often asked.

This article will provide a brief overview

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

Examples of combination products may in

of what lasik eye surgery technique is and what you need to do to qualify for it. It's not just a matter of presenting yourself to a surgeon and sayin

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

g..."I want lasik!" While lasik is an extremely safe procedure, it is surgery nevertheless and your surgeon will need to determine several things about

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 and your eyes before accepting you as patient.

The Qualification Process

First of all, you will need to consult your doctor. Discuss with him/he

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

Combination pro

r your situation and the problems you are experiencing and an analysis will be made of your situation. Remember, not everyone will be suitable for lasi

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

k eye surgery. some of the reasons you may be rejected include:

- being under the age of 18.
- being pregnant
- eyes must be in a healthy co

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

dition

At a young age, peoples eyes are still in the evolving stage and any complications which may exist could improve over time. Young people are en

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

couraged to give it a little extra time before considering lasik treatment.

With pregnancy, lasik is discouraged because of the refraction or bending

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

of light due to hormonal changes. Surgery response may be a little skewed for pregnant woman and this also applies to women during the nursing stage.

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

If you have been having ongoing problems with your eyes and they are not in a healthy or stable condition then lasik may not be an option for you. Your

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

Following aspects would a

doctor will determine this and be extremely forthright about it. Rejection in this instance is usually a precautionary measure.

Lasik Eye Surgery Tec

dd to the challenges in developing combination products:

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

hniques

Lasik eye surgery is a relatively safe and painless procedure. Lasik surgery techniques are such that the procedure is quick and is usually pe

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

rformed within 10-20 minutes. Local anaesthethic is used.

It involves a laser cut flap on the eye cornea and lifting it and is then followed by a lase

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

re-shaping of the tissue underneath it. When completed the flap is then replaced. No stitching is required and the healing process begins. Protection

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

is placed over the eye so the cornea isn't subject to outside damage.

The healing process is usually very quick, in fact, in some cases, people have b

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

Professional from academic institutions, pharmaceutical industries, health care indust

een able to resume work duties the following day however, most patients are advised to take a few days off. Side effects aren't immediately noticeable

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

although some mild irritation may be felt in the form of slight burning or itching. Depending on the level of discomfort, medication may be prescribed.

.

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

Lasik surgery techniques are amazingly effective and once you qualify, the decision will be yours on whether to have the surgery. The success rate is

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

Companies that provide selfless information through particip

extremely high and the benefits certainly outweigh the negatives. Ultimately, it will be your decision on whether it is worth the slight risk involved

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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