In response to questions posted to ICH M10 comment period, a number of Questions and Answers have been devised to provide clarity around some of the bioanalytical issues covered in the Guideline.
This Question and Answer (Q&A) document is intended to provide additional clarification and to promote convergence and improve harmonization of the bioanalytical method validation and study sample analysis.
The scope and organization of this Q&A document follow that of ICH M10…
