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Typical information products contain CDs and/or DVDs as part of the package. When you're working with a disc duplicator you'l

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

l need to decide if you want to replicate or duplicate the discs you're going to have produced. People want to know what the d

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

Examples of combination products may in

ifference between the two is and does it matter at all? This article takes a look at the two methods and what it means to you.

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

CD/DVD duplication in its purest definition means to copy discs. Actually, there are two different means to copy a disc - re

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

plication and duplication

Replication

Starting with a glass master that contains the data for the disc, a metal stamper is f

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

Combination pro

ormed. The stamper is loaded into a molding machine and molten polycarbonate is injected into the mold thereby manufacturing t

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

he disc with the data stamped into the disc. A reflective aluminum layer is applied and the discs are printed with artwork.

D

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

plication

Starting with pre-manufactured blank recordable discs, the data is “burned” onto the discs one at a time. The proce

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

ss takes several minutes per disc depending on the speed of the recorder and the amount of information you are recording.

Doe

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

s It Matter?

Some people will tell you not to duplicate audio or video but only replicate. Others say there’s no difference a

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

t all. There is no data difference between a processed duplication and a glass mastered replication disc.

But, there are some

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

Following aspects would a

differences and sometimes they do have an impact. The reality has more to do with the playback equipment than the manufacturi

dd to the challenges in developing combination products:

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

ng process. Older, “set top” DVD players (hooks to your TV) sometimes have problems playing duplicated discs but rarely have p

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

roblems with replicated discs (rarely doesn’t mean never).

Industry experts estimate that among the current installed drive b

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

se (computers and players) about 98% of the CD players will play duplicated CDs, and about 90% of the DVD players will play du

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

plicated DVDs. Recordable media is somewhat vulnerable to sunlight.

Printing

No matter which way you go, your discs should

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

Professional from academic institutions, pharmaceutical industries, health care indust

have a label. Why? So people will know which side is up and which side is the read side of your disc. Replicated discs are typ

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

ically silk screened. Duplicated discs are usually either thermal printed or paper labeled.

The ultimate decision is yours of

.

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

course as to whether you’ll have your discs replicated or duplicated. You’ll have to weigh the larger up front cash commitmen

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

Companies that provide selfless information through particip

t with replication vs. your ability to sell your product and the potential differences between replicated and duplicated discs

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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Well-known brands fire synapses associated with positive emotions, self-identification and rewards. Weak brands either don't register or provoke activity in parts of the brain associated with negative emotion.

For a business, non-profit or association manager, they could be fatal, coming as they do in four bitter flavors. Mistake #1 – You limit your PR activity pretty much to placing product and service...

Even small businesses benefit from this modern advertising method with less expense than that of conventional advertisement in print and media. It is also easier design this advertisement than producing conventional advertisements.

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