Thomas Singer

TL;DR: It is established that the homologous PSST of mitochondria and NQO6 of bacteria have a conserved inhibitor-binding site and that this subunit plays a key role in electron transfer by functionally coupling iron-sulfur cluster N2 to quinone.

TL;DR: A proposal to refine regulatory criteria for conducting a two-year rat study to be based on assessment of histopathologic findings from a rat six- month study, evidence of hormonal perturbation, genetic toxicology results, and the findings of a six-month transgenic mouse carcinogenicity study has the potential to eliminate over 40% of rat two- year testing on new pharmaceuticals without compromise to patient safety.

TL;DR: The genome sequence of a long-tailed macaque female of Mauritian origin is determined using a whole-genome shotgun sequencing approach and allows high-resolution genotyping and microarray-based gene-expression profiling for animal stratification, thereby allowing the use of well-characterized animals for safety testing.

TL;DR: This white paper presents principles for validating proarrhythmia risk prediction models for regulatory use as discussed at the In Silico Breakout Session of a Cardiac Safety Research Consortium/Health and Environmental Sciences Institute/US Food and Drug Administration–sponsored Think Tank Meeting on May 22, 2018.