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EMA Guidelines on Metabolism Studies Effective Feb 2012

  
  
  
  
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Metabolism & Residue Kinetics of Veterinary Drugs in Food-producing Animals

Veterinary medicines have an important role in the control of disease and prevention of animal suffering but also have the potential to cause harm if incorrectly used. Statutory controls have therefore been established to protect consumers from the effects of harmful residues of these medicines in their food.



Challenges of Validating Small Molecule LC-MS/MS Biomarker Methods

  
  
  
  
Challenges of Validating Small Molecule LC-MS/MS Biomarker Methods presentation

Biomarkers in drug development - The quantification of small molecule exploratory biomarkers can present a significant added challenge over and above that faced for regulated bioanalysis of xenobiotic drugs.  With an increase in the use of biomarkers in drug development, limited sample volume and endogenous assay validation, the development of robust high-throughput multianalyte assays has become a regular challenge.  Whilst “fit-for-purpose” assay validations are proposed for large molecule biomarker analysis, when and where is this applicable to small molecule LC-MS/MS assays?



Use of a CAPA System in Handling Anomalous Bioanalytical Results

  
  
  
  
Use of CAPA System presentation

Use of a CAPA system in handling anomalous results – with a focus on maintaining GCP compliance. A CAPA (corrective and preventative action) system is a useful tool in managing anomalous results. The advantage of a CAPA system is that Quality Assurance become responsible for monitoring the progress of the investigation and ensuring it is documented correctly and closed out in a timely manner. Also, if an electronic CAPA system is used it is possible to monitor trends in the nature and frequency of anomalies and report these to management.



Drug Transporters - Emerging Technologies

  
  
  
  
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Drug Transporter Interactions

Review of In Vitro Approaches and Models

Drug transporters are increasingly being implicated as a source of drug–drug interactions (DDIs) and potential organ specific toxicity in humans and interactions with these membrane bound proteins are becoming increasingly important to assess during drug development as recent regulatory draft guidance reflects.



Challenges in Developing Anti-Drug Antibody Ligand Binding Assays

  
  
  
  
Presentation on Challenges in Developing Anti-Drug Antibody Ligand Binding Assays

Challenges in Developing Anti-Drug Antibody Ligand Binding Assays. The 2011 EBF Open Symposium – Less is More was held on the 16-18 November at the Hesperia Tower hotel, Barcelona, with a focus on new trends in bioanalysis and new technology developments. The versatile and diverse program combined regulated bioanalysis themes with technological and scientific developments for small and large molecule bioanalysis. This year’s meeting attracted over 400 attendees with presentations from Novartis, GSK, Shire and many more. 



Environmental Fate Presentation at Crop World 2011

  
  
  
  
eFate Crop Study

Crop World Global Conference 2011

Crop World Global 2011 attracted more than 700 delegates, speakers, exhibitors and exhibition visitors from 75 countries.



14C Radiosynthesis; Diels Alder Solutions to Challenging Syntheses

  
  
  
  
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International Isotope Society; 26th Northeast US Chapter Symposium

The 26th International Isotope Society Northeast US Chapter Symposium took place on October 27th 2011 in Morristown NJ.



Plasma Protein Binding Method Comparison Poster at ISSX

  
  
  
  
Plasma Protein Binding Poster

ISSX 17th North American Meeting

The 17th North American Meeting of the ISSX society was held in Atlanta, USA (16-20 October 2011). Presentations were focused on toxicity, transport and enzyme regulation. 



Large Scale Performance Evaluation of MALDI-ToF MS

  
  
  
  
Large Scale Performance Evaluation of MALDI-ToF MS Poster

Large Scale Performance Evaluation of MALDI-ToF MS in a Central Reference Laboratory Setting - At last month's 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) (September 17-20, Chicago, US) we announced our adoption of Bruker's MALDI Biotyper for bacterial identification, following a successful year-long trial. The trial period of Bruker’s MALDI Biotyper has proved very successful and we are confident that this technology represents the future of bacterial identification.



PK Modelling and Simulation to Predict Clinical PD Endpoints

  
  
  
  
Using PK modelling and simulation presentation

Leading academics and delegates from around the world gathered last week at our exclusive Autumn Seminar, which covered a wide range of topics in latest approaches of the use of PK, PD and PK/PD modelling in drug development. Over 60 delegates from the pharmaceutical industry met to hear a series of presentations and take part in lively debate with key academics and industry thought-leaders.



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