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Introduction This interoperability event has been organized by the MPLS &

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

Frame Relay Alliance and the European Advanced Networking Test Center (EANTC), and hosted

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

Examples of combination products may in

y Upperside.

The interoperability test scenarios were performed using a multi-vendor netwo

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

k of real MPLS routers, complemented by emulators. Test methodologies were checked and impr

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

ved throughout the testing. The end result was that the network was successfully constructe

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

Combination pro

. This achievement, along with the advantages and capabilities of this technology, will be

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

emonstrated at the MPLS World Congress in Paris, February 11-13, 2004. The demo was hotstag

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

d at EANTC labs in Berlin, Germany, in January 2004.

The test scenarios were designed spec

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

fically for this showcase, based upon the experiences of previous interoperability test eve

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

ts. They covered new MPLS capabilities which have not been shown before. The focus was on d

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

monstrating differentiated services over MPLS and MPLS traffic engineering. Multi-vendor MP

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

Following aspects would a

LS/BGP VPNs and Layer 2 Ethernet VPNs (Martini and VPLS) were configured to prove that serv

dd to the challenges in developing combination products:

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

ces were traffic engineering-enabled and could process differentiated services.

To ensure

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

he success of the event, a one week hotstaging event with all the participating vendors was

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

conducted before the MPLS World Congress. It took place at the EANTC (European Advanced Net

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

orking Test Center) in Berlin, Germany. The test plan was defined by the Interoperability W

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

Professional from academic institutions, pharmaceutical industries, health care indust

rking Group of the MPLS & Frame Relay Alliance, including EANTC and UNH IOL (University of

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

ew Hampshire Interoperability Lab).

This is an introduction to the White Paper issued by t

.

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 MPLS Forum/Frame relay alliance EANTC. for the complete Paper, please visit elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

//www.rad.com/Article/0,6583,18681,00.html" target="_blank">RAD data communication site

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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