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Consider all the materials that we make stuff out of and how important they are t

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

o us. If you ask the average person they will immediately think of steel, aluminu

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

Examples of combination products may in

m, glass and concrete, then they will think a bit and say Plastic.

Ah ha, Plasti

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

c indeed, yes plastic and they probably should have said that first you see. Afte

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

r all, as one gentleman recently told me plastic is invisible and we do not think

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

Combination pro

much about it until one day we watch our mashed in bumper pop-back out and bingo

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

, good as new. Plastic is a material that is quite often invisible. But it is so

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

vitally important to everything we make.

He is right about the plastic being inv

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

isible, that is why I like those public relations commercials for the plastic ind

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

ustry, where everything in the room starts disappearing. Hilarious, but it sends

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

out the right message so good for the American Plastics Association, I say; Excel

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

Following aspects would a

lent PR and point well taken too.

Something so simple as plastic, now think wher

dd to the challenges in developing combination products:

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

e would be without it? Can you even begin to imagine. I mean just look at that co

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

mputer in front of you. Heck the whole thing is made out of plastic? How about th

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

at cell phone right there by you? Yet plastic too, consider you cannot really go

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

anywhere without plastic.

Think of how much of your car is made of plastic? Your

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

Professional from academic institutions, pharmaceutical industries, health care indust

remote control for your TV, have the stuff in your kitchen and what about your r

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

ecreational toys? Yep, look at all that plastic. Why it is simply everywhere. Now

.

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

I do not work for the American Plastics Association and I am not even in that bu

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

Companies that provide selfless information through particip

siness, but I just would like you to take a moment and consider all this in 2006.

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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