Advice Pool - Health and Fitness

Have you decided to throw away your eyeglasses? Have you changed your mind

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

and you want to never use contact lenses again? How will you handle drivi

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

Examples of combination products may in

ng or reading when you have myopia, hyperopia or astigmatism? With LASIK.

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

What is LASIK?

LASIK is a rather new type of refractive

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

surgery designed to reshape the cornea and produce clearer vision for peop

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

Combination pro

le with myopia, hyperopia or astigmatism. After the surgery your dependenc

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

y on spectacles or contact lenses will either be considerably decreased or

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

you will not need glasses at all.

LASIK means Laser-Assisted In Situ

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

Keratomileusis. Your cornea is reshaped with a laser. A flap is cut i

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

n the cornea with a knife, called microkeratome. The surgeon fol

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

s the flap and exposes the stroma. The pulses of the laser vaporize a port

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

Following aspects would a

ion of the stroma, the middlesection of the cornea. Afterwards the flap is

dd to the challenges in developing combination products:

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

replaced and your vision should be 20/20.

The most you can expect from r

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

efractive surgery is the convenience of a reduced need for corrective lens

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

s. To achieve that convenience, you must accept some risk. We hope to help

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

you minimize that risk, but risk cannot be eliminated.

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

Professional from academic institutions, pharmaceutical industries, health care indust
rong> The target of the refractive surgery is the convenience of a reduce
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
need for corrective eyeglasses. However, in order to reach this goal you
.

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
must also accept a series of risks. Your surgeon will surely try to minimi
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
ze those risks, but you should be aware that the risks cannot be eliminate

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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