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You’ve loaded up the kids into your fully-packed family station wagon, I meant late-model luxury SUV. You’re cruisin’ towards the Bay Bridge and bamm, the pounding temples ret

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

urn as you round the corner and see nothing but brakelights. Yes, the annual two hour holiday gridlock kicks in just to make the crossing. Subwoofers resonate with your throbb

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

Examples of combination products may in

ing headache, your wife goes into instant negative recall mode about vacation choices, your kids are fighting over the ipod. You get the picture, right?

So you simply surrend

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

r, dial into ESPN and commiserate with your newly-found road warrior comrades. Your buff and sparkling SUV inches towards the EZ Pass gateway to Eastern Shore heaven with the

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

rest of your posse. Some wise guy yells through his sunroof, “Next 4th of July, I hear that each car will have its own lane and this traffic will be a thing of the past!”

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

Combination pro

What!?

“..each car will have its own lane…“ This guy’s nuts. Imagine a roadway (and a Bay Bridge) that would have a dedicated lane for every vehicle that needed access

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 some destination on any given day. Just a bit wild, totally inefficient let alone impractical, not cost-effective and like the comment from the future Nobel Peace Prize Win

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

er, nuts.

Doing It The “Old Way”: Not Really Nuts However, That’s How Analog Telephone Lines Work When many of us ordered the telephone lines we currently use for our busine

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

ss, we didn’t have many options. We actually did purchase one line (or one traffic lane as used in the above scenario) for each inbound or outbound conversation (or vehicle ne

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

ding access) required on a daily basis.

Lines were bought the same as our residential lines perhaps with the added feature of hunting within a multi-line group. Maybe we got

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

really fancy and pushed the envelope by routing a toll-free 800 to our main published number. In other words, we did what Mr. Sunroof blabbered in the traffic jam. Bought indi

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

Following aspects would a

vidual telephone lines for voice or fax that sit idle until used.

Today, our business technology choices are more dynamic. Thus for any organization with 8 or more lines and

dd to the challenges in developing combination products:

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

ecurring monthly telecommunications expenditures of $500, ISDN PRI is one of the best choices you can make to improve your bottom line.

ISDN-How Does It Work And What Are Its

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

Sum Parts? How Does ISDN PRI Improve My Business Telephone Assets? We all know that the one lane one car approach is incredulous. There just isn’t enough real estate to go a

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

ound for that economic model. Well, with business telephone line capacities that exceed the threshold I outlined above, a shared digital PRI approach is the smart choice for m

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

any.

A PRI offers 23 B channels for voice, video and data traffic via a T-1. The 24th channel or D channel, is used for signaling. For high volume applications when combining

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

Professional from academic institutions, pharmaceutical industries, health care indust

PRIs, you only use one signaling channel, freeing one additional B channel for regular traffic. You can run 20-60 numbers over one PRI. This allows for better call center back

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

up, overflow and alternate routing. Digital in nature, PRI's are equally good at handling voice or data. PRI has become the chosen access method for voice-over-IP traffic.

He

.

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

e’s what you get:

Elimination of pricey inbound/outbound voice lines

Better rates for local/long distance

Routing of faxes more efficiently

Retaining and porting of existi

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

Companies that provide selfless information through particip

ng numbers to PRI

Consolidation of internet access on same “pipe”

Scale-up easily with minimum cost

Voice, data, video, and fax on PRI

Free enhanced features, ie. Caller I

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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As ISO 9001 becomes a way of life for the global business community, ISO 14000 is almost ready to debut with its own set of standards for voluntary environmental compliance.

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