E-Articles - Health and Fitness

When it comes to working with lasers, safety is paramount. Not only are lasers very powe

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

rful, but the human eye is particularly sensitive to laser light. Retinal and corneal da

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

Examples of combination products may in

mage can occur very easily and can be impossible to reverse. The retina is the surface a

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

t the back of the eye that transmits images to the optic nerve. The hazards of laser lig

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

ht here are obvious, as many lasers have the power to burn through this delicate tissue.

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

Combination pro

Permanent blindness can result from this exposure to laser light if proper eye protecti

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

on is not used.

The motto must therefore be prevention rather than cure. The best and mo

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

st efficient way of preventing laser damage is wearing laser safety glasses. These are

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

special glasses specifically designed to block certain wavelengths of laser light that c

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

ould damage eyesight.

When choosing a pair of laser safety glasses, ensure that they are

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

designed for the type of laser you are using. They should allow a large field of visio

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

Following aspects would a

n and be comfortable if you are going to be wearing them for protracted periods. They s

dd to the challenges in developing combination products:

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

hould also be a good fit. You don’t want them to slip around as this can result in injur

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

y due to impaired field of vision.

It can be a challenge to find the right pair of glass

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

es, ones that do not impair vision, but protect it none the less. There can occasionally

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

be issues with the user sweating into the glasses. This is unpleasant and can be a dang

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

Professional from academic institutions, pharmaceutical industries, health care indust

er if vision is compromised. Thus, the eyewear you choose should be comfortable, as unc

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

omfortable eyewear often results in people failing to wear it at all.

This raises the mo

.

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

st important part of laser safety, wearing the safety glasses. You can have the best pro

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

Companies that provide selfless information through particip

tection in the world, but it will do you no good at all sitting on the bench next to you

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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