On the utilisation and characterisation of external biotransformation systems in in vitro toxicology: protocol for a critical review Here we propose to specifically examine hazard assessment needs for biotransformation systems (BTS) to meet an acceptable quality standard level for regulatory applications. This includes consideration of reporting adequate, consistent characterisation of the BTS to ensure reliability, relevance, and reproducibility. This critical review protocol on the

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... , characterisation, and methodology of BTS in in vitro toxicology has been prepared according to the PRISMA-P guidelines and the European food safety authority's (EFSA) guidelines for systematic reviews.