A wide-ranging assessment of safety is expected to be made using animals such as rats, dogs and fish, to protect the health of humans and environmental species. By working together with industry to discuss best-practices and collecting data and experience, numerous opportunities have been identified to refine toxicology study procedures to improve animal welfare or to use minimized study designs using fewer animals.
Advances in bioanalytical techniques have opened up the potential to use smaller sample volumes (microsamples as low as 5 µl) to assess drug and chemical exposure in blood, plasma and/or serum. Whilst the technique is primarily a refinement, it also permits a reduction in animal use if additional (satellite) groups are no longer required.
Maximising the success of bile duct cannulation (BDC) studies
Recommendations for best practice across various aspects of rat BDC studies to maximise the amount of useful data generated using the fewest animals possible, whilst ensuring the highest possible standards of animal welfare.
Recommendations that move away from inclusion of recovery animals in toxicology studies supporting first-in-human trials as the default approach, to instead encourage science-based case-by-case considerations.