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Network Time Protocol (NTP) provides algorithms and defines messages for the synchronisation of time clients to an accurate time reference. This article discusses how to configure a Li

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

nux NTP Time Server to synchronise time with an Internet based public NTP Server.

NTP server systems fall into two categories: primary reference servers and secondary reference server

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

Examples of combination products may in

s. Primary reference servers use an external timing reference to provide time, such as GPS or radio clocks. Secondary reference servers synchronise with primary reference NTP servers a

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

d offer slightly reduced accuracy. Primary reference servers are designated stratum 1 servers, while secondary servers have a stratum greater than 1.

The NTP Distribution

The NTP sou

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

rce code is freely available from the Network Time Protocol web site. The current version available for download is 4.2.4. NTP is available for the Linux operating systems with ports a

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

Combination pro

ailable for Windows NT. Once the source code is downloaded, it should be configured, compiled and installed on the host machine. Many Linux operating systems, such as RedHat, offer NTP

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

RPM packages.

Configuring NTP

The ‘ntp.conf' file is main source of configuration information for a NTP server installation. Amongst other things, it contains a list of reference cl

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

ocks that the installation is to synchronise. A list of NTP server references is specified with the ‘server' configuration command thus:

server time-a.nist.gov # NIST, Gaithersburg, M

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

ryland NTP server server time-c.timefreq.bldrdoc.gov # NIST, Boulder, Colorado NTP server

Controlling the NTP Server Daemon

Once configured, the NTP daemon can be started, stopped a

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

nd restarted using the commands: ‘ntpd start'; ‘ntpd stop' and ‘ntpd restart'. The NTP server daemon can be queried using the ‘ntpq –p' command. The ntpq command queries the NTP serve

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

for synchronisation status and provides a list of servers with synchronisation information for each server.

NTP Access Control

Access to the NTP server can be restricted using the ‘

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

Following aspects would a

restrict' directive in the ntp.conf file. You can restrict all access to the NTP server with:

restrict default ignore

To only allow machines on your own network to synchronize with t

dd to the challenges in developing combination products:

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

he server use:

restrict 192.168.1.0 mask 255.255.255.0 nomodify notrap

Multiple restrict directives can be specified in the ntp.conf file to restrict access to a specified range of c

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

mputers.

Authentication Options

Authentication allows a matching passwords to be specified by the NTP server and associated clients. NTP keys are stored in the ntp.keys file in the f

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

ollowing format: Key-number M Key (The M stands for MD5 encryption), e.g.:

1 M secret 5 M RaBBit 7 M TiMeLy 10 M MYKEY

In the NTP configuration file ntp.conf, specify which of the

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

keys specified above are trusted, i.e. are secure and you want to use. Any keys specified in the keys file but not trusted will not be used for authentication, e.g.:

trustedkey 1 7 10

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

Professional from academic institutions, pharmaceutical industries, health care indust

The NTP server is now configured for authentication.

Client Configuration for Authentication

The client needs to be configured with similar information as the server, however, you

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

may use a subset of the keys specified on the server. A different subset of keys can be used on different clients, e.g.:

Client A)
1 M secret
7 M TiMeLy

trustedkey 1 7

Cli

.

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

nt B)
1 M secret
5 M RaBBit
7 M TiMeLy
10 M MYKEY

trustedkey 7 10

Essentially authentication is used by the client to authenticate that the time server is who he

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

Companies that provide selfless information through particip

says he is, and that no rogue server intervenes. The key is encrypted and sent to the client by the server where it is unencrypted and checked against the client keys to ensure a match

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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