Genotoxicity evaluation of medical devices: A regulatory perspective.

This review critically evaluates our current regulatory understanding of genotoxicity testing and risk assessment of medical devices. Genotoxicity risk assessment of these devices begins with the evaluation of materials of construction, manufacturing additives and all residual materials for potential to induce DNA damage. This is followed by extractable and/or leachable (E&L) studies to understand the worst case and/or clinical exposures, coupled with risk assessment of extractables or leachables.

Biocompatibility studies on cerium oxide nanoparticles - combined study for local effects, systemic toxicity and genotoxicity implantation route.

An implantation study of cerium oxide nanoparticles (CeO2-NP) combined with 28-day systemic toxicity and genotoxicity studies aligned to current regulatory standards was conducted. The results suggested that local tissue reactions caused by CeO2-NP was minimal (implantation irritation index of less than 3) and was better tolerated than most other implant materials tested in our laboratory. Furthermore, CeO2-NP showed virtually no systemic toxicity or micronucleus induction in bone marrow implantation route.

Mutant prevention concentration and PK-PD relationships of enrofloxacin for Pasteurella multocida in buffalo calves.

This study validated the use of mutant prevention concentration (MPC) and pharmacokinetic and pharmacodynamic (PK-PD) modeling approach for optimization of dose regimen of enrofloxacin to contain the emergence of Pasteurella multocida resistance. The PK and PD characteristics of enrofloxacin were investigated in buffalo calves after intramuscular administration at a dose rate of 12 mg/kg. The concentration of enrofloxacin and ciprofloxacin in serum were determined by high-performance liquid chromatography.