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