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Every computer must have a unique number in order to work properly in a network or on the Internet. This number is called address because it

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

makes possible for a computer to be found by other computers - ( something like the human addresses! ) -and to establish a communication wi

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

Examples of combination products may in

h them.

So we have IP address: Internet Protocol address. This number is in the form of XXX . XXX . XXX . XXX where XXX is an integer num

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

ber between 0 and 255. ( DOTTED QUAD: four group of decimal numbers separated by a dot ). Computers don't understand our decimal system bu

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

only electrical signals like on - off, so we must use the binary system (base 2 not base 10) where a number is composed by a series of 0

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

Combination pro

and 1. Example: 7 is represented by 00000111. Every binary cypher, that is 1 or 0, is a bit and 8 bits makes one byte. So 255 is,in bin

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

ry,11111111. Since every group of the IP address is formed by 8 bits and there are four groups (or four bytes ), we say that an IP address

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

is 32 bits long ( 8 x 4 = 32 ). Example 192.0.2.79 , in binary, looks like this: 11000000000000000000001001001111 Since there are 2 cyph

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

rs - 0 and 1 - it is possible to have 4.294.967.296 ( 2^32 ) of different combinations of addresses.

Every IP addresses shows two things:

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

the network to which the computer belongs and the host, that is the number of the computers. There are private IP addresses ( computers NO

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

connected to the Internet) and public IP addresses ( computers CONNECTED to the Internet ).

IP addresses are divided in classes: A - B -

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

Following aspects would a

C - D - E

Class A: IP addresses between 1.0.0.0 and 127.255.255.255. The first byte identifies the networks, the next 3 bytes the host

dd to the challenges in developing combination products:

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

We have 127 networks and 16.777.216 hosts.

Class B: IP addresses between 128.0.0.0 and 191.255.255.255. The first 2 bytes identify

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

the networks, the next 2 bytes the hosts. The first byte is limited to 128 - 191, so we have 16384 networks and 65536 hosts.

Class C:

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

IP addresses between 192.0.0.0 and 223.255.255.255. The first 3 bytes identify the networks, the last byte the hosts. The first byte i

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

s limited to 192 - 223, so we have 2.097.152 networks and 256 hosts

Class D: it is used for multicast, that is when just one host is broad

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

Professional from academic institutions, pharmaceutical industries, health care indust

asting and all the others are receiving.

Class E: for future use

Private IP addresses:
From 10.000 to 10.254.254.254
From 172.1

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

6.0.0 to 172.31.254.254
From 192.168.0.0 to 192.168.254.254
IP addresses may be dynamic or static.
Dynamic when the addre

.

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

ses changes every time that a computer or network is connected to the Internet - the ISP gives a different address at every connection.

Sta

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

Companies that provide selfless information through particip

tic when the address is still the same.

There will be a new kind of IP addresses, IPV6 ( base 16 ) which will allow to have more addresses

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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