Your Space - Health and Fitness

Are you at the point that things up close are not as sharp as they used to be? So somebody suggested a pair of reading glasses to help out. That pair of +1.00 rea

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

ders worked great for some time, then without warning they seem to fail, requiring you to get even a stronger pair of specs.

Is it possible that by wearing readi

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

Examples of combination products may in

g glasses your near vision deteriorated? Ready for the good news, you are only helping your self be wearing reading glasses. Correcting your vision does

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

ot make it worse, glasses simply bend light in a manner so it hits the back of your eye properly.

So when and why do you need reading glasses? If you are approac

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

ing 40, congratulations, you are also approaching presbyopia. Presbyopia is the medical term for loss of accommodative near vision. Basically, there is a lens ins

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

Combination pro

ide your eye that has been doing all the focusing for you. The lens is elastic and has the ability to adjust shape and, much like a camera, focus your eye from fa

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

to near.

When you were a little kid, it was possible to focus on objects as close as a couple inches away from your eye. Try that now, go ahead and try to read

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

his print closer and closer. Depending on your age, it may be blurry anywhere from a couple inches to almost a couple feet! Or perhaps you are already wearing rea

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

ing glasses to help you see up close.

The reason you notice this is because of that focusing lens, inside your eye, that we mentioned earlier. There are three pa

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

rts of the body that continue to grow throughout life: Your nose, your ears, and your crystalline lens. Your lens grows in layers, much like an onion. As it grows

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

your lens slowly loses its elasticity making it more difficult to focus up close. Because it is so gradual we really don’t notice it until we reach our 40’s and

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

Following aspects would a

t that time, we reach for a pair of reading glasses.

What do reading glasses actually do? They simply magnify the image which adjusts the focal length. This allo

dd to the challenges in developing combination products:

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

s you to see the fine details again while holding your reading material at a comfortable distance. By simply magnifying an image, it is not possible to weaken you

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

r eyesight. What many people notice is that at age 42, a pair of +1.00 readers may work great for the newspaper and dinner menus. They are happy with their new r

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

aders and not overly inconvenienced to pull them out occasionally. But then, after a few years, they seem to need them more and more. And all of a sudden that pai

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

of +1.00 readers is being upgraded to +1.50 or +2.00.

This progression is very natural and has to do, again, with the lens inside your eye losing its accommodat

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

Professional from academic institutions, pharmaceutical industries, health care indust

ve ability. So what are we to do now that we need readers? That’s simple, have fun with them. Reading glasses

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

are a fact of life today for most people over the age of 40. And the great news is that eyewear designers have made tons of fun and funky frames designed spe

.

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

ifically for you and your reading glasses needs.

So accept the fact that you will read a lot easier with a great pair of reading glasses, and most important, rea

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

Companies that provide selfless information through particip

ize that magnifying an image is perfectly healthy and only relaxes your eyes. Have fun with it, make sure your next pair of frames make you look and feel fabulous

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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