Guidance

Study designs for pharmaceutical and chemical development

Projects providing guidance to reduce animal use or refine procedures within toxicology studies.

Introduction

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.

Optimal duration of mAb chronic studies

Recommendations to suggest when three-month toxicity studies are likely sufficient to support late-stage clinical development and registration for mAbs, based on a novel weight-of-evidence model, and further opportunities to minimise animal use in mAb development.

Publication: Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach

Publication: The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain

You can read more about this project on our project page: Re-evaluating the need for mAb chronic toxicity studies.

Microsampling

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.

Visit our dedicated resource page on microsampling, aimed at guiding strategy and encouraging the adoption of microsampling techniques within academia and the pharmaceutical and chemical industries.

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.

Publication: Maximizing the success of bile duct cannulation studies in rats: recommendations for best practice

You can read more about this project on our project page: Maximising the success of bile duct cannulation studies.

Reducing the use of recovery animals

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.

Publication: Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials

You can read more about this project on our project page: Reducing the use of recovery animals.

Review of the use of two species in regulatory toxicology studies

Results from an international working group of 30 pharmaceutical companies and regulatory bodies highlighting opportunities to use one rather than two species for long-term toxicity studies

Publication: Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation

You can read more about this project on our project page: Review of the use of two species in regulatory toxicology studies.

Reducing animal use in monoclonal antibody (mAb) development

A comprehensive programme to reduce the use of animals (in particular, non-human primates) in monoclonal antibody (mAb) development, whilst supporting the drug development process and patient safety.

Publication: Challenges and opportunities for the future of monoclonal antibody development: Improving safety assessment and reducing animal use

You can read more about this project on our project page: Reducing animal use in monoclonal antibody development.