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

Interviews Regulated bioanalysis

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
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