Tiered approaches to chromatographic bioanalytical method performance evaluation: recommendation for best practices and harmonization from the Global Bioanalysis Consortium harmonization team.

The A2 harmonization team, a part of the Global Bioanalysis Consortium (GBC), focused on defining possible tiers of chromatographic-based bioanalytical method performance. The need for developing bioanalytical methods suitable for the intended use is not a new proposal and is already referenced in regulatory guidance language. However, the practical implementation of approaches that differ from the well-established full validation requirements has proven challenging. Advances in technologies, the need to progress drug development more efficiently, and emerging new drug compound classes support the use of categorized tiers of bioanalytical methods. This paper incorporated the input from an international team of experienced bioanalysts to surmise the advantages and the challenges of tiered approaches and to provide recommendations on paths forward.

Evaluation of enzymic assay for paracetamol: clinical and forensic experiences.

The performance of the enzymic paracetamol assay (Cambridge Life Science, UK) was evaluated for use in clinical and forensic analyses and compared with gas-liquid chromatography and EMIT (Syva) systems. It was found to be precise, accurate and rapid for the analysis of paracetamol in serum, with a possible application for the quantitative screening of post mortem blood.