07 October 2019
Bioanalysis publishes GCC consolidated feedback to ICH on the 2019 ICH M10 bioanalytical method validation draft guideline
Bioanalysis has published a supplement presenting the Global CRO Council for Bioanalysis’ (GCC) feedback to the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline from the 13th GCC Closed Forum (LA, USA, 5 April 2019).
Bioanalysis is delighted to publish the “GCC consolidated feedback to ICH on the 2019 ICH M10 bioanalytical method validation draft guideline” supplement written by the Global CRO Council for Bioanalysis (GCC). This supplement presents the GCC’s collaborated feedback to the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline, published in February 2019, gathered from the 13th GCC Closed Forum (LA, USA, 5 April 2019).
63 senior-level participants from eight countries representing 44 bioanalytical CRO companies attended the forum to analyse the newest ICH M10 Bioanalytical Method Validation Draft Guideline. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the ICH M10 Bioanalytical Method Validation Draft Guideline and to build unified comments to be provided to the ICH. The members worked through the guideline, line by line, to provide thorough feedback on each point.
To help conduct this, seven teams were formed and designated portions of the guideline. These were headed by Corey Nehls (PPD Laboratories; VA, USA); Mike Buonarati (Intertek Pharmaceutical Services; Manchester, UK); Stephanie Cape (Covance; WI, USA); Rafiq Islam (Celerion; NE, USA); Christina Satterwhite (Charles River Laboratories; NE, USA); Chad Briscoe (PRA Health Sciences; KS, USA); Roger Hayes (ICON Laboratory Services; NY, USA). Seven surveys were then developed based on each line of the guideline and the results, main trends and additional comments from the meeting have been collaborated and presented in this supplement.
The editors of Bioanalysis would like to take this opportunity to thank the team leaders and all the GCC members.
The full supplement is available to read online here.
Also, to view interviews with some of the team leads from the Forum, visit our sister site Bioanalysis Zone.
The journal Bioanalysis was launched in 2009 and focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques.
Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.
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