5 February, 2013
Bioanalysis is delighted to announce that the March 2014 issue will be a special focus on “Taking the tiered approach beyond metabolite quantitation” guest edited by Philip Timmerman. The issue will focus on the principles and applications of a tiered approach in a variety of areas, as well as looking at risk-based and fit-for-purpose validation.
In 2010, a white paper published by the European Bioanalysis Forum outlined a tiered approach to metabolite quantification. By using a tiered approach, a fit-for-purpose method can be applied to metabolite quantification at different stages of drug development, potentially enabling more focus on developing deeper scientific knowledge of the drug, and saving time and money.
Guest edited by Philip Timmerman, a proponent of the tiered approach and an author on the 2010 paper, the March 2014 special issue of Bioanalysis will focus in depth on the tiered approach.
The special issue will discuss the principles of the tiered approach and aims to stimulate discussion on further applications beyond the currently accepted use in metabolite quantification.
- Current applications of the tiered approach
- Future applications of the tiered approach
- Hurdles of applying the tiered approach, such as the pharma–CRO interface, regulatory acceptance and the interplay between science and processes
- Risk-based approaches
- Fit-for-purpose validation
This themed issue is intended to provide a stepping-stone for the bioanalytical community to further develop the principles of the tiered approach in metabolite quantification. The issue will also look at other possible areas of application, where the tiered approach could be applied in place of full validation in line with current regulatory guidelines, including (but not limited to):
- Tissue analysis and imaging,
- In vitro sample analysis
- Microsampling and dried matrix sampling (DMS and DBS)
- Urine analysis
We welcome the submission of a wide range of articles to this issue, full details of which can be found in our author guidelines.
Guest editor: Philip Timmerman
Publication: Bioanalysis Volume 6 issue 5 (March 2014)
Deadline for submissions: 15th October 2013
If you or your colleagues are interested in contributing to this special focus issue, please do get in contact. We look forward to hearing from you.
Ryan De Vooght-Johnson