European Medicines Agency guideline on bioanalytical method validation: what more is there to say?

“Overall, the content of the European Medicines Agency guideline is not dramatically different to that of the US FDA Guidance and supporting White Papers.” The European Medicines Agency (EMA) published a draft guideline on bioanalytical method validation in November 2009 (hereafter referred to as the ‘Guideline’) and following a consultation period until the end of May 2010, the final Guideline was adopted in July 2011 and became effective on 1 February 2012. Until the implementation of the Guideline, the US FDA 2001 ‘Guidance for Industry’ on this topic was almost universally adopted by the pharmaceutical and contract-research industries as the...

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