Advice Pool - Health and Fitness

In case you decided to have the LASIK surgery, you must find out if you are a LASIK candidate during a visit to an ophthalmologist. Y

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

our visit will have two stages:

1. Eye examination

The examination is painless and it's needed so that the doctor

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

Examples of combination products may in

ould give you the correct diagnosis. Based on the result of the appointment you will decide if the results of the surgery will satisf

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

you and if you want to continue. Stop wearing contact lenses for at least 4 weeks prior to the examinations as they change the shape

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

of the cornea and the surgeon will not be able to correctly map your eye.

2. Correction surgery

The eye is prepar

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

Combination pro

d for the intervention with anesthetic eye drops. The painless surgery doesn't take longer than 5-10 minutes. The surgeon only superv

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

ses the actions of the computer. You will leave the clinic as soon as the intervention is complete. You will return for checkups that

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

will last a few minutes.

Are You A Good Candidate?

Is your answer YES to the following questions?

* Are you at l

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

ast 18?

* Are your eyes healthy? They don't have corneal scars or eye diseases.

* Is your myopia mild to moderate?

* Do you know 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

e risks and the benefits of the intervention?

* Can you pay for the surgery? This type of intervention is not usually covered by the

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

health insurance.

Then you are a good candidate for a correction surgery. Please contact the closest medical unit to get further inf

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

Following aspects would a

ormation about the locations where the intervention can be done, the costs and the specialists.

Is the Surgery A Risk to Me?

dd to the challenges in developing combination products:

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

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You are NOT a good candidate for the surgery if:

* you do not like taking risks.

* you cannot afford the surgery.

* you

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

situation raises additional risks (you are under 20 or over 65, you are a pregnant woman or you are breastfeeding).

* you are a min

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

or. This type of surgery is not approved for people under 18.

* you participate in action sports (boxing, martial arts etc.)

If the

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

ophthalmologist considered you to be a good candidate, talk to your doctor about his experience with LASIK surgery. The complications

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

Professional from academic institutions, pharmaceutical industries, health care indust

and the results vary among surgeons and you want to get the best results based on his experience. 1 On the whole, you must be realis

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

tic regarding the results of the surgery. In most cases, the surgery will not eliminate the need for but will only diminish considera

.

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

ly your contact lenses usage.

Reources:

1. Vidaurri-Leal, JS. Complications in 5000 LASIK procedures. Refractive

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

Companies that provide selfless information through particip

urgery 1998 Reshaping the Future, a publication of American Academy of Ophthalmology Subspecialty Day 1998 - Refractive Surgery; 61-6

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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Advice Pool - Lasik Interventions - Target Patiens and Risk Candidates

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