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Could you imaginge the world without computers, medical equipment, toys, cookware, sports equipment and clothes? Suppose you could

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

step inside a time machine and go back 60 or 100 years. You may easily convince yourself a day without cars, telephones, and tele

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

Examples of combination products may in

vision—maybe even computers—might be kind of fun. Have you thought about the little things, though? Little things are often what 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.

re missed the most. How would you clean your teeth for instance? Toothbrushes are made out of plastics. You would not even wake up

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

in time in the morning. Have a look at your alarm-clock. How many parts made out of plastics does it have? Without plastics ther

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

Combination pro

e would not be any means of transport. A huge number of parts for airplanes, cars, ships and trains are made out of plastics. But

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

where do plastics come from? The first synthetic plastic was made from the plant material cellulose.

In 1869, John Wesley Hyatt,

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

an American printer and inventor, found that cellulose nitrate could be used as an inexpensive substitute for ivory. The mixture c

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

ould be plasticized with the addition of camphor. Celluloid, as this new material was called, became the only plastic of commercia

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

l importance for 30 years. It was used for eyeglass frames, combs, billiard balls, shirt collars, buttons, dentures, and photograp

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

ic film. In 1951, two young research chemists for Phillips Petroleum Company in Bartlesville, made discoveries that revolutionize

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

Following aspects would a

d the plastics world. Today, the plastics they discovered—polypropylene and polyethylene—are used to produce the vast majority of

dd to the challenges in developing combination products:

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

the thousands of plastics products all over the world. The raw material for plastics is petroleum. The word plastic comes from the

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

Greek word plastikos, meaning "able to be molded." Plastics can be processed in many ways. The main process used to form plastics

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

is called extrusion molding. A heated plastic compound is forced continuously through a forming die made in the desired shape (lik

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

e squeezing toothpaste from a tube, it produces a long, usually narrow, continuous product). The formed plastic cools under blown

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

Professional from academic institutions, pharmaceutical industries, health care indust

air or in a water bath and hardens on a moving belt. Rods, tubes, pipes, and sheet and thin film (such as food wraps) are extruded

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

then coiled or cut to desired lengths.

So far so good. Now close your eyes and immagine your every day life without plastics. Wha

.

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

t would you miss most? Your television, your cellular phone, your eyeglasses or would it be safety? Remember that most safety prot

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

Companies that provide selfless information through particip

ections are made out of plastics. http://www.otm-it.com/

Agathe Freudenstein agathe@elib.org

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Affordable Options Exist for Retail Security: Security Mirror, Fake Security Camera, Door Entry Chime lead the list.

The mergers in the Cinema Industry are making the cinema advertising playing field smaller, in the end it seems that there can be only one...

Rapid staff turnover is expected to escalate. That means that just when companies are devoting more time to finding new talent, they have to find ways to encourage current employees to stay.

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