Advice Pool - Health and Fitness

Lasik is basically a two-phase process. The first phase is the pre-operative phase, while the second phase is the procedure itself. The pre-operative phase of lasik varie

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

s for different patients. While some may be asked to stay without their contact lenses for a week, in some cases the timeline may extend to 10 days.

The pre-operative ph

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

Examples of combination products may in

se is vital to the success of the procedure in its entirety, as it helps the patient prepare for life without glasses or contact lenses, while enabling doctors to examine

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

the shape of the patient’s cornea and determine the kinds of irregularities existing, if any. This helps the doctor know if the patient suffers from astigmatism, a distor

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

tion of the shape of the cornea that results in poor vision.

The examination of the cornea itself is a scientific process that involves using a scanner, controlled by a

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

Combination pro

omputer to create a map of the patient’s cornea by shooting low-power lasers at it. Once the corneal surface has been mapped, the surgeon works out the different paramete

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

s critical to the success of the surgery. These include the amount of tissue to be removed from the cornea, the location of the tissue, and other related parameters. Duri

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

ng this phase, the doctor usually advises the patient to use a mild antibiotic. This step is taken to ensure that there are minimal chances of an infection after the actu

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

l procedure.

The operation itself is quite simple, and is performed using a local anesthetic. This is usually an eye drop, and the patient remains awake during the proce

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

ure. Depending on the requirements of the patient, and also his general physical condition, the surgeon may opt for general anesthesia. However, this is an exception, and

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

is not done usually.

The surgeon first uses the microkeratome to make an incision into the cornea. Other choice of application may be a femtosecond laser. Afer making th

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

Following aspects would a

e incision, the surgeon next cuts out a flap of the cornea at the appropriate location which he has determined from his studies of the corneal surface during the pre-oper

dd to the challenges in developing combination products:

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

tive phase.

Cutting out the flap of the cornea exposes the mid-section of the cornea, the stroma. The third step in the process involves the surgeon realigning the strom

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

using an excimer laser. During this entire process, a computer continuously monitors the position of the eye itself. The computer operates at very high speeds; the compu

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

ter tracks the eye movement up to 4,000 times per second.After realigning the stroma, the surgeon places back the flap of cornea.

As seen above, lasik offers numerous ad

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

antages to patients and surgeons. However, it is not totally without side effects. While the complications are not commonplace, they do exist. There are quite a few compl

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

Professional from academic institutions, pharmaceutical industries, health care indust

cations related to lasik, and while all of them are not seen in a patient, different patients may exhibit different symptoms, or a combination of symptoms.

A patient, du

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

ring the post-operation phase, may sometimes experience starbursts when he is near a light source. The patient sees this kind of an illusion usually in the form of a halo

.

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

Other common side effects include double vision, a wrinkling of the corneal flap, induced astigmatism, which is basically secondary astigmatism (the patient may not have

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

Companies that provide selfless information through particip

had astigmatism prior to the operation), sensitivity to light, under- or over-correction of the corneal defect, fluctuation in visual acuity, and also decentered ablation

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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