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CD Replication, Audio Cd Replication, CD-Rom Replication are all produced from CD Replication machines an

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

d are different from the CD Duplication. People around were confuse over the differences between both of

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

Examples of combination products may in

them.

CD Replication is where one have a master copy to replicate it into bulks. The process of CD Repli

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

cation involves glass mastering, injection moulding, sputtering and printing.

Glass Mastering in CD Repl

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

ication process means that a master copy is given to the replicator and the master copy will be put into

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

Combination pro

a machine where they want to make a stamper (mould) out for the exact content of the master CD.

When the

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

stamper is done, it will then be fixed into an injection machine mould and PC (plastic resin) will be 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

ulded according to the stamper grooves. The transparent plastic which has a shape of the CD now have all

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

the groves that is moulded out from the stamper which was made in the glass mastering process.

The trans

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

parent CD will then go through a sputtering process where aluminum target are used. This creates a reflec

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

tive layer where CD player can beam its laser and have a reflective layer reflecting it.

After the sputt

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

Following aspects would a

ering process, it will go through a lacquer process where it is a liquid form to protect the layer. After

dd to the challenges in developing combination products:

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

this process the replica will be going through scanners where every piece is QC'ed.

After the above pro

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

cess the replica is then printed using silkscreen of offset plates where output films are involved. This

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

is roughly what CD Replication means.

On the other hand Cd duplication simply means that you buy a CD-R

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

and burn it using a burner or CD burner stacked.

CD Replication and CD duplications biggest different is

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

Professional from academic institutions, pharmaceutical industries, health care indust

that every piece out from the CD Replication process is QC'ed and CD duplication is all depend on the CD

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

-R brought and laser head of the CD burner. It is impossible to test CD's from CD Replication process as

.

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

normal cd Duplicators will not have scanner on them. the second disadvantage of CD-r is that you do not

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

Companies that provide selfless information through particip

knwo what grade of Cd-r that you are buying. Expensive does not mean good and cheap does not mean grade C

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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