Corporate Banner
Satellite Banner
Mass Spectrometry
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Thermo Fisher Scientific Introduces New Incurred Sample Reanalysis Information Kit for Reliable Quality Assessment of Bioanalytical Methods

Published: Friday, August 13, 2010
Last Updated: Friday, August 13, 2010
Bookmark and Share
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.


Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,900+ scientific posters on ePosters
  • More than 4,200+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Thermo Fisher Scientific Receives IVDD CE Mark for LC-MS Products
Now available to clinical laboratories in Europe for general in vitro diagnostic use.
Friday, September 11, 2015
Thermo Fisher Q3 Revenues up 31 Percent
Thermo Fisher announced that revenues grew 31% to $4.17 billion for the third quarter ended September 27, 2014.
Thursday, October 23, 2014
Thermo Fisher, NRLs Team to Confirm Dioxins in Feed and Food
Thermo Fisher Scientific worked closely with national reference labs (NRLs) in the European Union to support the development of new regulation.
Monday, September 08, 2014
Thermo Supports Distinguished Analytical Chemistry Seminar Series at NC State
An endowment established by the company provides opportunities to attend presentations by leading analytical chemistry authorities.
Tuesday, August 19, 2014
Reimagining UHPLC
To learn more about the new Vanquish UHPLC system from Thermo Fisher Scientific we spoke to Wulff Niedner, Director of HPLC Product Marketing.
Thursday, July 17, 2014
Thermo Registers San Jose Facility with FDA
The site has established a quality system in accordance with the FDA Quality System Regulations to design and manufacture devices for analyzing samples from patients for in vitro diagnostic use.
Monday, June 16, 2014
Thermo Fisher, BioAnalytix Collaborate
Collaboration to develop advanced biopharmaceutical analysis workflows.
Thursday, June 12, 2014
Thermo, Nuclea Biotechnologies Collaborate to Develop Diabetes Markers
Companies pooling their expertise to develop novel multiplexed research methods for high-throughput quantification of native insulin and its therapeutic analogs.
Monday, June 02, 2014
Thermo, Evans Analytical Group Form Joint Effort to Expand GDMS Applications
Companies team up to apply pulsed glow discharge mass spectrometry to analysis of non-conductive materials, depth profiling.
Thursday, May 15, 2014
Thermo Reports 22% Revenue Rise in Q1 2014
Results include the addition of Life Technologies as of February 4, 2014, and exclude the previously announced related divestitures as of March 22, 2014.
Wednesday, April 23, 2014
Thermo, Harvard Establish Center for Multiplexed Proteomics
Thermo Fisher Scientific Center for Multiplexed Proteomics at Harvard Medical School aims to expedite understanding of complex disease mechanisms.
Thursday, March 20, 2014
Thermo Completes Life Tech Acquisition
The completion of the transaction follows the receipt of all required regulatory approvals.
Tuesday, February 04, 2014
Thermo Reports 6% Q4 Revenue Growth
Thermo Fisher Scientific Inc. reported its financial results for the fourth quarter and full year ended December 31, 2013.
Friday, January 31, 2014
Biosimilar Characterization R&D Facility Opens in Austria
University of Salzburg, Sandoz and Thermo Fisher Scientific collaborate to advance protein-based pharmaceutical development, production, QA/QC.
Wednesday, October 23, 2013
Thermo Fisher Scientific and the DTU Form Systems Biology Collaboration
Orbitrap Fusion Tribrid LC-MS technology to power new cellular signaling network research.
Monday, September 02, 2013
Scientific News
Microbes Take Their Vitamins
Scientists exploit organisms' needs in order to track 'vitamin mimics' in bacteria.
Keeping a Specimen's Story Straight
Imagine 96 people standing shoulder to shoulder, not touching and attempting to breathe only the air un-exhaled by the others. Sound impossible?
Portable Kit Can Recover Traces of Chemical Evidence
A chemist at the National Institute of Standards and Technology (NIST) has developed a portable version of his method for recovering trace chemicals such as environmental pollutants and forensic evidence including secret graves and arson fire debris.
Diagnosis of Two Rare Childhood Diseases Improved
For the first time, researchers have developed tests that could improve the diagnosis of two rare childhood diseases known as congenital disorders of glycosylation (CDGs) and metachromatic leukodystrophy, and that could even lead to new treatments for CDGs.
Cleaning Out the Membrane Each Day
Cell membranes are made up of a lipid bilayer that is constantly changing due to the flux of material in and out of the cell.
New Test for Cancer and Diabetes Biomarkers
University of Warwick researchers developed the test to help identify molecules in collagen.
Cooperating Bacteria Isolate Cheaters
Bacteria, which reciprocally exchange amino acids, stabilize their partnership on two-dimensional surfaces and limit the access of non-cooperating bacteria to the exchanged nutrients.
Novel Approach to Understanding Brain Function
Russell Poldrack scanned his brain to create the most detailed map of brain connectivity ever.
Periodic Table of Protein Complexes
New tool helps to visualise, understand and predict how proteins combine to drive biological processes.
Stockpiling Proteins
New web-based tool allows researchers to measure protein dynamics in embryogenesis.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!