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Every web site has a name, of course, like for instance, www.google.it and so on. Its files are on a server that is a computer in some part of the wo

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

rld. So when we write a domain name (www.google.it) in the address line of our browser, ( the URL line ) we can see the web site we were looking for.

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

Examples of combination products may in

But computers do not work with real names but with numbers only. So there must be a way to let them understand what we are writing in our browser.

DNS

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

- Domain Name Service - is a system which translates a domain name into numbers.

The web site www.google.it is translated into 216.239.39.104. In fact

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

if we write this numbers in the address line of our browser, we are redirected the web site google.it

This numbers are the IP - Internet Protocol - a

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

Combination pro

dress.

Any computer connected to the Internet has a unique IP address, in the form of XXX.XXX.XXX.XXX, where XXX is an integer between 1 and 255. This

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

number identifies the computer and the network to which it is connected.

There are a lot of computers all around the world acting as DNS servers whic

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

h have large databases of IP addresses corresponding to domain names. The whole Internet is divided in zones with a DNS server.

Root Name Server:

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

A: There are 12 operators for root DNS at 13 unique IP addresses.
A - VeriSign Naming and Directory Services
B - Information Sciences

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

Institute (University of Southern California)
C - Cogent Communications
D - University of Maryland
E - NASA Ames Research Center

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

F - Internet Systems Consortium, Inc.
G - U.S. DOD Network Information Center
H - U.S. Army Research Lab
I - Autonomica
J - VeriS

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

Following aspects would a

ign Naming and Directory Services
K - RIPE NCC (Reseaux IP Europeens - Network Coordination Centre)
L - ICANN (Internet Corporation for Ass

dd to the challenges in developing combination products:

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

gned Names and Numbers)
M - WIDE Project

Each letter from A to M identifies a single IP address. They are situated in more than 35 countr

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

es ( more than 84 locations ), most of them outside the USA. Not all the exact locations of the root servers are known because of security reasons.

T

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

his is how it works:

We want to go to www.symantec.com

1)Our computer asks our ISP ( Internet Service Provider - that is the company which provides u

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

the Internet connection ) DNS server what is the number (IP) of this web site. If this server knows it, our computer will be connected with the comput

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

Professional from academic institutions, pharmaceutical industries, health care indust

r where this site is.

2)If our ISP DNS server has not that information,it will ask other DNS servers until it finds the IP number which it is looking

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

for. After that, our computer will be connected with the computer where this site is.

3)If it is not possible to find that address - wrong number or

.

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

he web site does not exist - our browser will not be able to show us that web site.

DNS propagation: it is the process which inserts a website IP numb

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

Companies that provide selfless information through particip

r into the DNS server around the world. It may take up to 72 hours. This is why a new website is not visible on the Internet before that period of time

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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BB link (for phorums):
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