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NTP or Network Time Protocol to give it its full name is an internet protocol designed to distribute precise time around a network. NTP is a UDP based protocol used to synchroni

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

ze system time on network infrastructure, such as servers, workstations and network equipment . This article describes how to utilise the Network Time Protocol authentication f

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

Examples of combination products may in

atures to authenticate time references when synchronizing clients to a NTP server.

NTP Server Security

Network Time Protocol is used to provide a precise time reference for ti

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

me critical applications. Therefore, NTP can pose a security risk if malicious users attempt to corrupt a NTP timestamp to create a false time on network equipment.

NTP provide

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

increased security in the form of authentication. Authentication is intended to overcome security risks by ensuring that any response received from an NTP time server has come

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

Combination pro

rom the intended reference. The client sends a request for time to a NTP server. The server then responds to the client with a precise timestamp along with one of a number of ag

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

reed encrypted keys. On receipt of the timestamp, the client un-encrypts the key and verifies it against a list of trusted keys. The client can then be sure that the received ti

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

estamp was indeed transmitted from the intended time reference. NTP utilises MD5 encryption (Message Digest Encryption 5), which is a 128-bit cryptographic hash function, which

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

utputs a fingerprint of the key. MD5 is a highly secure encryption algorithm, widely used on the internet for authentication and security purposes.

NTP Authentication Keys

NTP

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

authentication keys are codes that are encrypted on both the server and client that are used to identify the NTP time server. NTP authentication keys are stored in a file usual

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

y called ‘ntp.keys'. Each authentication key consists of a key number, an encryption code and the key itself.

E.g. NTP server keys:

2 M VisioN
5 M SeRvEr
7

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

Following aspects would a

M TiMeLy
10 M MYKEY
12 M TiDy
14 M MaGic

The authenication key number acts as a reference to the specified authentication key. The encryption code specif

dd to the challenges in developing combination products:

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

ies the type of encryption to be utilised, e.g. ‘M' for MD5 encryption. The actual keys must be identical on both the client and the NTP time server. The client may utilise a su

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

-set of the authentication keys specified on the NTP Server. The keys are case sensitive.

E.g. client keys:

5 M SeRvEr
7 M TiMeLy
10 M MYKEY
14 M Ma

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

ic

Trusted Authentication Keys

Trusted authentication keys are specified in the NTP server configuration file, ‘ntp.conf'. Trusted keys specify which subset of keys are curren

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

tly activeand can be used by the NTP server. This allows a sub-set of trusted keys to be selected from a potentially large keys file. The trusted keys specifier allows key refer

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

Professional from academic institutions, pharmaceutical industries, health care indust

nces to be changed easily without editing the keys file. Trusted keys are selected using the ‘trusted-keys' configuration command.

E.g.

trusted-keys 7 10 14

This specifies th

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

t authentication keys with the key references of 7, 10 and 14 are trusted and can be used by the NTP installation.

NTP Security Summary

Essentially, authentication is used by

.

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

the client to authenticate that the NTP server is who he says he is, and that no rogue server intervenes. The key is encrypted and sent to the client by the server where it is

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

Companies that provide selfless information through particip

nencrypted and checked against the client keys to ensure a match. Authenication provides NTP with a high level of security to prevent malicous tampering of timestamp information

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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