Pharsight launches PK/PD storage for small businesses

11-Aug-2009 - Last updated on 12-Aug-2009 at 10:24 GMT

Pharsight has launched PKS Online to provide small companies with a PK/PD data and analyses storage system, which it claims saves users money and can improve early-stage development.

The product is an online version of Pharsight Knowledgebase Server (PKS). Moving it online eliminates the need to spend time on money on custom deployment and continuous IT support, according to Pharsight, making the product ideal for businesses with limited staff and resources.

PKS Online retains all the features of Pharsight’s pharmacokinetics and pharmacodynamics (PK/PD) software. These include the ability to capture, store, manage, analyse, summarise and report knowledge related to existing drugs or new compounds.

In addition PKS Online can integrate with other Pharsight products, including Phoenix, WinNonlin and PKS Reporter. The tool is available on a subscription basis, with flexible licensing and validation support services.

Pharsight’s original PKS software has been available for seven years. During this time it has been installed by 25 pharmaceutical companies and Office of Clinical Pharmacology at the US Food and Drug Administration (FDA), according to Pharsight.

Benefits of PK storage

PK/PD modelling is encouraged under the FDA’s Critical Path Initiative, which aims to modernise the drug development process, and PKS Online can help with this. Furthermore, storage of PK data for internal and regulatory review ensures compliance with 21 CFR Part 11.

Companies using PKS Online to handle this task will be able to access the data from anywhere within the organisation and external development partners can also be allowed to view it. Pharsight believes that this can improve scientific productivity.

By performing PK/PD modelling Phase I or II a company can asses patient response and therefore probably success in the market, allowing failures to come earlier in the development process.