Perspectives on the draft ICH M10 guidance: an interview with Eric Woolf

In this Bioanalysis Zone interview, Eric Woolf (Merck; PA, USA) provides an overview of the draft ICH M10 guidance for bioanalytical method validation, indicating why there is a need for new guidance despite many BMV guidance currently being available. Eric also elucidates how the finalized guidance will be compiled with industry feedback, before sharing his thoughts on the potential disadvantages of such a collect consensus guidance.

Read Eric's interview in Bioanalysis here

If you enjoyed this interview, you might also like…

Panel discussion: ICH M10 draft bioanalytical method validation guideline
FDA announces final guidance for ’Bioanalytical Method validation,’ now available
Panel discussion: FDA guidance, transitioning skills and future hopes for the bio lab