September 2021

It is common knowledge to those submitting drug substances for regulatory assessment, that an in silico assessment of mutagenic potential may be conducted in lieu of carcinogenicity or bacterial mutagenicity data for any impurities. A key requirement in ICH M7 states that “Two (Q)SAR prediction methodologies that complement each other should be applied. One methodology […]

“Our technology is designed by scientists, for scientists, in collaboration with industry stakeholders and regulators” At Lhasa Limited we often talk about the importance of industry involvement in shaping our direction. This involvement and collaboration takes places across many areas – perhaps most notably in recent years within the Mirabilis and Effiris consortia, where at