Reliable Quality Assessment of Bioanalytical Methods

SAN JOSE, Calif. – Thermo Fisher Scientific Inc., the world leader in serving science, today announced the introduction of a new incurred sample reanalysis (ISR) information packet. This vendor-neutral ISR

guide is designed to educate pharmaceutical scientists on using the technique to effectively assess the quality of bioanalytical methods. It contains up-to-date information on changing regulatory guidance, including the official US Food and Drug Administration CDER bioanalytical method

validation guidance paper, the latest Crystal City workshop report and a selection of papers from the AAPS Journal exploring ISR methods and best practices. This comprehensive kit provides scientists with the information required to establish a robust ISR program and is available to download from

www.thermoscientific.com/isr

ISR was recently established as a viable method for re-analyzing samples obtained from in-vivo studies in order to test the reproducibility of bioanalytical methods. To facilitate efficient use of the ISR method, pharmaceutical companies and contract research organizations need detailed guidance. Thermo Fisher developed this new kit to provide thorough direction for ISR assessment, studies that should be conducted, the selection of samples, acceptance criteria and reporting of results. During drug development, bioanalytical methods are validated and used to quantify drugs and their metabolites in a variety of biological matrices.

In response to industry requirements for dependable laboratory information management systems (LIMS) that incorporate superior ISR capabilities as standard, Thermo Fisher offers a comprehensive solution for ISR which includes Thermo Scientific Watson LIMS 7.4 software integrated with the TSQ

series mass spectrometers. The data processing and reporting features of the LIMS have been substantially improved, yielding better functionality and greater ease-of-use. Watson LIMS, the most commonly used bioanalytical data system in the pharmaceutical industry, is now capable of accommodating the ISR samples within the same run as the regular bioanalytical samples.

For more information about Thermo Fisher’s new ISR information kit, please call 1-800-532-4752, e-mail analyze@thermo.com or visit www.thermoscientific.com/isr

Thermo Scientific is part of Thermo Fisher Scientific, the world leader in serving science.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of more than $10 billion, we have approximately 35,000 employees and serve customers within pharmaceutical and

biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which

offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications. Visit

www.thermofisher.com.