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Laboratories involved in the analysis of clinical trial samples have recently received new regulatory guidance from EMA and FDA. The EMA reflection paper for laboratories that perform the analysis of clinical trial samples issued in 2012, the EMA method validation guideline released in 2012 and the new guidance on method validation provided as a draft by the FDA in September 2013 will clearly help to better understand the expectations of the regulators. In its draft guidance the FDA has taken a clear position and requires validating methods for parameters that are crucial biomarkers for the assessment of safety and efficacy. In this presentation we will discuss these requirements in the context of the EMA reflection paper and the EMA validation guideline and also point towards the special challenges in the validation of analytical methods for endogenous compounds that are used as biomarkers for safety and efficacy.