What does the harmonization of in silico safety assessments mean for extractables and leachables?

The ICH M7 guideline1 presents the types of methodologies that are relevant to assess mutagenic impurities. The guideline goes further than simply mentioning that QSAR methods and analogs should be considered prior to conducting an experimental study, and it details two complementary methodologies (statistical and expert rule-based), and how the results should be considered to […]

So many pieces of information!

The movement of toxicology away from an observational-based paradigm and towards a mechanism-based one is ongoing. One pertinent question is how to combine data across mechanistic pathways to derive an overall assessment of hazard and what level of confidence should be placed in such a result. Further, where data gaps exist, how could in silico […]