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As we started the project of our web site, we knew that the proprietary software costs would be too high for our financial resources. Our only option then was to make use of Open Source Code softwares.

However, within the Open Source C

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

ode there are lots of softwares to choose from, and it?s up to the system analyst/programmer to pick the ones that best suit the project goals.

In our case, we picked Linux as our operating system. However we faced a big question: Whic

; 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 Linux distribution ? There are dozens of linux distributions, each one with specific advantages, sometimes with or without paid services.

We chose linux Slackware because we thought that it would suit better our needs, in terms of st

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

ability and reliability. Slackware is a conservative distribution, meaning that it only offers in its distribution package kernel versions and third party libraries, once it?s been proved to be stable and reliable. As a result, Slackwar

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

e is one the most stable Linux operating system on the market. If the user wishes the most recent Linux kernel and libraries, we recommend to look for a different distribution.

Another reason for us picking Slackware, was because of it

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

Combination pro

text interface, which at the beginning may become a bit difficult, in the long run however it offers a better understanding of the Linux environment. This way most of Slackware configurations are done thru text scripts.

Once it was se

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

t the operating system, we picked Apache as our web server. Apache is one of the most popular web server in the internet. For server programming language, we chose PHP. Also, a very popular programming language. Our experience with Apac

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

he/PHP proves that this setup is very reliable, working extremely well in our production environment. For workstation programming language, we chose javascript, which besides of having a simple syntax, it offers lots of resources.

Apac

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

he web server is really a complete web server. Also, it can become very complex with many configuration setups.

For our database, we picked Postgresql. This database has been made available to the public for more than 15 years, and bes

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

ides of being well debugged, it offers so many resources that it has become one of the best database options from Open Source Code softwares. Extremely reliable, Postgresql has reported cases where there have been databases in productio

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

with over 4 terabytes. Besides all of that, Postresql is not the most popular Open Source Code database. A matter of marketing ? Probably.

As for the programming language PHP, we had to use an object oriented application structure. Th

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

Following aspects would a

ere are many PHP application structures being offered with Open Source Code license. Object oriented application is very important, because it makes programming very easy and scalable up to the point where the system may grow without ma

dd to the challenges in developing combination products:

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

ny problems. Also, it helps to keep PHP code separated from HTML, with the help of some specific libraries, such as Smarty. We make use of Smarty library and we believe that it is a very important resource, which can even make web pages

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

faster thru the use of its cache functions.

Also a very important set of libraries worth mentioning for PHP systems, is the PEAR libraries. In PEAR web site, among the many libraries being offered, there are the database interface DB

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

and the MAIL_QUEUE, which sends emails thru the use of database.

As we came to the end of our project, we had to use some sort of real time database replication. For that we chose the DRBD and Heartbeat libraries. The use of database r

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

plication is very important and should not be postponed. Just after 3 months our system got into production, our server hard disk became bad. Thru the use of DRBD/Heartbeat we were able to put the system back into production within seco

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

Professional from academic institutions, pharmaceutical industries, health care indust

nds, without loosing any data. DRBD/Heartbeat replication is done thru the use of a lan network between the server and slave nodes.

Our project also makes use of ImageMagick (enlarge and reduce images), Iptables (firewall), Tsearch2(te

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

xt search in portgresql) and Mon (linux monitoring tasks).

Also a very important library worth mentioning is the pseudo APC compiler for PHP. Speed is always a critical factor for internet sites.

Our web site is already in production

.

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

and based upon our experience we can say that the Open Source Code softwares we picked, proved to be extremely reliable and stable. Open Source Code softwares can certainly be an excellent option for developing web sites.

Roberto Sedyc

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

Companies that provide selfless information through particip

ias IT Consultant

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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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