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To pass the BSCI exam and earn your CCNP, you've got to know ISIS inside and out. There ar

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

e many similarities between ISIS and OSPF, but one major difference is that ISIS has three

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

Examples of combination products may in

different types of routers - Level 1 (L1), Level 2 (L2), and L1/L2.

L1 routers are contain

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

ed in a single area, and are connected to other areas by an L1/L2 router. The L1 uses 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

1/L2 router as a default gateway to reach destinations contained in other areas, much like

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

Combination pro

an OSPF stub router uses the ABR as a default gateway.

L1 routers have no specific routing

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

table entries regarding any destination outside their own area; they will use an L1/L2 rou

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 as a default gateway to reach any external networks. ISIS L1 routers in the same area m

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

ust synchronize their databases with each other.

Just as we have L1 routers, we also have

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

L2 routers. Anytime we're routing between areas (inter-area routing), an L2 or L1/L2 route

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

must be involved. All L2 routers will have synchronized databases as well.

Both L1 and L

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

Following aspects would a

2 routers send out their own hellos. As with OSPF, hello packets allow ISIS routers to for

dd to the challenges in developing combination products:

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

m adjacencies. The key difference here is that L1 routers send out L1 hellos, and L2 route

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

rs send out L2 hellos. If you have an L1 router and an L2 router on the same link, they wi

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

l not form an adjacency.

An ISIS router can act as an L1 and an L2 router at the same time

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

; these routers are L1/L2 routers. An L1/L2 router can have neighbors in separate ISIS are

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

Professional from academic institutions, pharmaceutical industries, health care indust

as. The L1/L2 router will have two separate databases, though - one for L1 routes and anot

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

er for L2 routes. L1/L2 is the default setting for Cisco routers running ISIS. The L1/L2

.

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

router is the router that makes it possible for an L1 router to send data to another area.

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

Companies that provide selfless information through particip

In the next part of my ISIS tutorial, we'll take a more detailed look at those ISIS hellos

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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